Clinical trial NCT06275087: Differences in Speed of Recovery From Anesthesia for Intraoral Surgery
Official title: Differences in Speed of Recovery From Anesthesia and Recovery of Muscle Strength in General Balanced Inhalation Anesthesia and Total Intravenous Anesthesia for Intraoral Surgery - Clinical Randomised Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intraoral Tumor
Keywords: TIVA
Propofol
Intraoral surgery
Postoperative recovery
recovery of muscle strenght
Lead sponsor: Clinical Hospital Centre Zagreb
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to compare two groups of patients going in general anesthesia for intraoral surgery, the first group TIVA with propofol and the second group inhalational with sevoflurane. The main questions it aims to answer are to asses speed and quality of recovery from general anesthesia.

Participants will fill out a questionnaire to evaluate the quality of recovery from anesthesia using the QoR-40 1h, 24h, and 30 days after waking up from anesthesia in comparison to the results of the same questionnaire before surgery. Also, the investigators will perform a hand grip and bite strength test on the patients after waking up from anesthesia in the operating room, after 1 hour in the recovery room, and after 24 hours compared to preoperative values.

The investigators will compare TIVA and Volatile groups to see if there are any differences in recovery seed, muscle strength recovery, postoperative nausea and vomiting, and shivering between groups.

Detailed description: After obtaining the approval of the ethics committee of KBC Zagreb and the Faculty of Dentistry of the University of Zagreb, the research will be conducted at KBC Zagreb.

Criteria for patient inclusion are:

* patients older than 18 years
* ASA status 1-2,
* Patients who have an indication for an intraoral surgical procedure (intraoral tumor excisions) longer than 30 minutes.
* patients who agreed to the research and signed the consent

Exclusion criteria are:

* ASA status 3 and higher,
* The need for postoperative care in the ICU,
* Surgery lasting more than 2 hours,
* Surgical procedures that in the operative plan include injuries to the grip of the masticatory muscles, the masticatory muscles themselves, and procedures on the bone, and thus may result in a difference in the strength of the bite. Masticatory muscles are defined as musculus pterygoideus lateralis, musculus pterygoideus medialis, musculus temporalis and musculus masseter.
* Surgical procedures on the bone where the bite force test alone could cause injury
* Patients with diseases of the neuromuscular junction and muscle diseases, myopathy, dystrophy
* Patients taking medications that can cause myopathy or muscle weakness
* Known allergies to drugs used in the trial,
* Refusing to participate

Participants will be randomly divided (1:1 randomisation) according to a predetermined randomization table (32) into the TIVA group and the Volatile group. After identification of the participants in the operating room, participants will be fitted with a peripheral venous line, electrocardiogram monitoring, non-invasive blood pressure measurement, pulse oximeter, capnograph, temperature probe, and bispectral index (BIS) of the electroencephalogram and neuromuscular monitoring, kinemiography with train-of-four (TOF , M-NMT, Drägerwerk AG \& Co. KGaA,) by recording the responses.

The initial anesthesiological induction procedure will not differ in both groups of patients. The drugs that will be used are sufentanil 0.3mcg/kg, propofol 2mg/kg, and cisatracurium 0.1mg/kg.

Participants will be intubated with an endotracheal tube and mechanically ventilated with a mixture of oxygen and air (inspiratory fraction of oxygen 40%) with a total flow of gas mixture of 3 L/min.

Anesthesia will be maintained in the volatile group with the inhaled anesthetic sevoflurane and single doses of cisatracurium. Cisatracurium will be repeated when the TOF ratio is greater than 5%, and the repeat dose will be 0.01 mg/kg. The depth of anesthesia will be controlled by BIS, maintaining values between 25 and 50. Recommended drug doses will be guided by TOF and BIS values.

In the TIVA group, anesthesia will be maintained with a continuous infusion of propofol (5-10 mg/kg/h) and single doses of cisatracurium. Cisatracurium will be repeated when the TOF ratio is greater than 5%, and the repeat dose will be 0.01 mg/kg. The depth of anesthesia will be controlled by BIS, maintaining values between 25 and 50. Recommended drug doses will be guided by TOF and BIS values.

At the end of the surgical intervention in both groups, the neuromuscular block will be antagonized with prostigmine (0.05 mg/kg) along with atropine (0.01 mg/kg) as soon as the patient begins to breathe spontaneously. Patients will then be extubated when the TOF index is greater than 90%

Muscle strength of all participants will be measured with a JAMAR hand dynamometer, and bite force with a gnathodynamometer (Bite force sensor, Monad electronics) in four time intervals:

1. Before introduction to anesthesia
2. After waking up from anesthesia in the operating room
3. 1 hour after waking up from anesthesia in the recovery room
4. After 24 hours from the operation

All patients will fill out the Quality of recovery-40 (Qor-40) questionnaire for assessing the quality of recovery after anesthesia and surgery in four time intervals:

1. Before introduction to anesthesia
2. 1 hour after waking up from anesthesia in the recovery room
3. After 24 hours from the operation
4. After 30 days from the operation Consent for the use of the QoR-40 questionnaire was obtained by the main researcher from the author, Professor P.S. Myles, and Dr. M. Miklić Bublić, who translated the questionnaire into Croatian.

Postoperative nausea and vomiting and postoperative shivering will also be recorded, as a binary outcome (yes/no), by visual assessment and interaction with the patient.

The time from the end of the operation to waking up will be monitored. Pain will also be recorded based on QoR40 and the visual analogue scale (VAS-scale) for pain assessment. The patient's chronic therapy is recorded, as is the need for postoperative analgesia.

Assuming medium to large effect size, test power of 80% and use of independent t-test for the primary objective and x2 test for the secondary objective with a statistical significance of 0.05, it is necessary to take a sample of 42 patients, 21 subjects per group. . The test for power calculation is G Power Version 3.1.9.6 (46). Assuming that part of the respondents will not be able to follow up until the end of the research, a sample of 50 patients will be taken, that is, 25 patients in each group. A review of similar studies confirmed the sample size (18,47,48). The results will be processed with IBM SPSS statistics v27. For scalar parametric data, the independent Student t test will be used, for non-parametric data, the Mann-Whitney U test, while categorical data will be processed with the Pearson χ² test.

Eligibility criteria: Criteria for patient inclusion are:

* patients older than 18 years
* ASA status 1-2,
* Patients who have an indication for an intraoral surgical procedure longer than 30 minutes.
* Surgical interventions on the soft tissues of the mouth, intraoral excision of tumors, operated through the transoral route
* Patients who agreed to the research and signed the consent

The exclusion criteria are:

* ASA status 3 and higher,
* The need for postoperative care in the ICU,
* Surgery lasting more than 2 hours,
* Surgical procedures that in the operative plan include injuries to the grip of the masticatory muscles, the masticatory muscles themselves, and procedures on the bone, and thus may result in a difference in the strength of the bite. Masticatory muscles are defined as musculus pterygoideus lateralis, musculus pterygoideus medialis, musculus temporalis and musculus masseter.
* Surgical procedures on the bone where the bite force test alone could cause injury
* Patients with diseases of the neuromuscular junction and muscle diseases, myopathy, dystrophy
* Patients taking medications that can cause myopathy or muscle weakness
* Known allergies to drugs used in the trial,
* Refusing to participate

Primary outcomes:
measure: "Quality of recovery from anesthesia" QoR-40 questionnaire
timeFrame: 1 hour, 24 hour, 30 day
Secondary outcomes:
measure: bite strength and hand grip strength
timeFrame: after waking in OR up to 10 min, 1 hour after waking, 24 hour after waking
measure: Postoperative nausea and vomiting
timeFrame: 24 hours
measure: Postoperative shivering
timeFrame: 2 hour
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: University Hospital Centre Zagreb
Study officials:
affiliation: UHC Zagreb
name: Ivan Šitum, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Diniz JA, Siqueira ADS, Araujo GM, Faro TF, Torres LHS, Oliveira E Silva ED, Laureano Filho JR. Intraoral Approach for Surgical Treatment of Psammomatoid Juvenile Ossifying Fibroma. J Craniofac Surg. 2020 May/Jun;31(3):e306-e309. doi: 10.1097/SCS.0000000000006171.
citation: Ferreira, C. C., Pereira, M. B. F., Bruzinga, F. F. B., Castro, H. H. O., Souto, G. R., Souza, P. E. A., & De Oliveira, L. J. (2022, September). AN UNUSUAL INTRAORAL LIPOMA: A CASE REPORT. Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology, 134(3), e119. https://doi.org/10.1016/j.oooo.2022.01.212
citation: Frerich, B. (2020). Complications in Maxillofacial Tumor Surgery. Complications in Cranio-Maxillofacial and Oral Surgery, 253-277. https://doi.org/10.1007/978-3-030-40150-4_13
citation: Tamunobelema, D. M. S., & Uruaka, C. I. (2023, March 11). General Anaesthetic Agents and its Implication on the Cardiovascular System: A Systemic Review. Saudi Journal of Medical and Pharmaceutical Sciences, 9(03), 171-183. https://doi.org/10.36348/sjmps.2023.v09i03.006
citation: Qurbani, B., & Karim, S. B. (2022, December 29). Comparison among complications of common intravenous anesthetic drugs during general anesthesia for patients undergoing surgery in Sulaimani city. Annals of the College of Medicine, Mosul, 44(2), 159-165. https://doi.org/10.33899/mmed.2022.136178.1166
citation: Fiorda-Diaz, J., Stoicea, N., & Bergese, S. (2017). Anesthetic Agents. Essentials of Neuroanesthesia, 123-129. https://doi.org/10.1016/b978-0-12-805299-0.00007-5
citation: Hao X, Ou M, Zhang D, Zhao W, Yang Y, Liu J, Yang H, Zhu T, Li Y, Zhou C. The Effects of General Anesthetics on Synaptic Transmission. Curr Neuropharmacol. 2020;18(10):936-965. doi: 10.2174/1570159X18666200227125854.
citation: Monisha, B., Madhusudhana, R., & Sujatha, M. (2023). Effects of Isoflurane versus Propofol for Postoperative Neurocognitive Recovery in Patients Undergoing Surgery under General Anaesthesia: A Randomised Clinical Study. JOURNAL OF CLINICAL AND DIAGNOSTIC RESEARCH. https://doi.org/10.7860/jcdr/2023/62147.17888
citation: Mayhew D, Mendonca V, Murthy BVS. A review of ASA physical status - historical perspectives and modern developments. Anaesthesia. 2019 Mar;74(3):373-379. doi: 10.1111/anae.14569. Epub 2019 Jan 15.
citation: Saha, D. S. C., & Seraji, D. S. I. (2023, April 16). A Comparative Study of Propofol and Sevoflurane for General Anesthesia in Laparoscopic Appendectomy. Scholars Journal of Applied Medical Sciences, 11(04), 753-757. https://doi.org/10.36347/sjams.2023.v11i04.014
citation: Yang L, Chen Z, Xiang D. Effects of intravenous anesthesia with sevoflurane combined with propofol on intraoperative hemodynamics, postoperative stress disorder and cognitive function in elderly patients undergoing laparoscopic surgery. Pak J Med Sci. 2022 Sep-Oct;38(7):1938-1944. doi: 10.12669/pjms.38.7.5763.
citation: Miao L, Lv X, Huang C, Li P, Sun Y, Jiang H. Long-term oncological outcomes after oral cancer surgery using propofol-based total intravenous anesthesia versus sevoflurane-based inhalation anesthesia: A retrospective cohort study. PLoS One. 2022 May 13;17(5):e0268473. doi: 10.1371/journal.pone.0268473. eCollection 2022.
citation: Zhou, Y., & Xu, T. (2022, January 24). Effect of propofol and sevoflurane on perioperative and postoperative outcomes in lung cancer patients after thoracoscopic surgery. Tropical Journal of Pharmaceutical Research, 20(4), 873-879. https://doi.org/10.4314/tjpr.v20i4.30
citation: Wu L, Li Y, Si J. Effects of sevoflurane and propofol on postoperative nausea and vomiting in patients with colorectal cancer placed under general anesthesia: a systematic review and meta-analysis. J Gastrointest Oncol. 2022 Dec;13(6):2963-2972. doi: 10.21037/jgo-22-783.
citation: Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. doi: 10.1093/oxfordjournals.bja.a013366.
citation: Miklic Bublic M, Miklic P, Barl P, Matas M, Sekulic A. CROATIAN VERSION OF THE QUALITY OF RECOVERY QUESTIONNAIRE (QoR-40): TRANSCULTURAL ADAPTATION AND VALIDATION. Acta Clin Croat. 2021 Jun;60(2):237-245. doi: 10.20471/acc.2021.60.02.09.
citation: Kim DH, Min KT, Kim EH, Choi YS, Choi SH. Comparison of the effects of inhalational and total intravenous anesthesia on quality of recovery in patients undergoing endoscopic transsphenoidal pituitary surgery: a randomized controlled trial. Int J Med Sci. 2022 Jun 13;19(6):1056-1064. doi: 10.7150/ijms.72758. eCollection 2022.
citation: Meng W, Yang C, Wei X, Wang S, Kang F, Huang X, Li J. Type of anesthesia and quality of recovery in male patients undergoing lumbar surgery: a randomized trial comparing propofol-remifentanil total i.v. anesthesia with sevoflurane anesthesia. BMC Anesthesiol. 2021 Dec 1;21(1):300. doi: 10.1186/s12871-021-01519-y.
citation: Shi CM, Zhou Y, Yang N, Li ZQ, Tao YF, Deng Y, Guo XY. [Quality of psychomotility recovery after propofol sedation for painless gastroscopy and colonoscopy]. Beijing Da Xue Xue Bao Yi Xue Ban. 2023 Apr 18;55(2):324-327. doi: 10.19723/j.issn.1671-167X.2023.02.017. Chinese.
citation: Kim SH, Ju HM, Choi CH, Park HR, Shin S. Inhalational versus intravenous maintenance of anesthesia for quality of recovery in patients undergoing corrective lower limb osteotomy: A randomized controlled trial. PLoS One. 2021 Feb 19;16(2):e0247089. doi: 10.1371/journal.pone.0247089. eCollection 2021.
citation: Tomita S, Matsuura N, Ichinohe T. The combined effects of midazolam and propofol sedation on muscle power. Anaesthesia. 2013 May;68(5):478-83. doi: 10.1111/anae.12172. Epub 2013 Mar 22.
citation: Wen LL, Lin WQ, Zhao WX, Li GC, Bai XH, Xiao JB. [Effect of sevoflurane versus propofol-remifentanil anesthesia on neuromuscular blockade by continuous cisatracurium infusion]. Nan Fang Yi Ke Da Xue Xue Bao. 2010 Jan;30(1):163-5. Chinese.
citation: Man, Mi, & Han. (2011, September 1). Influence of sevoflurane and propofol on the neuromuscular block effect of cisatracurium. Medical Journal of Chinese People's Liberation Army, 36, 973-975. https://www.semanticscholar.org/paper/Influence-of-sevoflurane-and-propofol-on-the-block-Man-Mi/eb40663a5683c9cc22116520104ca02a66c8b6de#citing-papers
citation: Pan, C., Xing, Y., Zhang, D., Liu, X., Zhou, Y., Shi, L., Xu, M., & Zhang, B. (2023, June 6). Combined remifentanil/sevoflurane in paediatric tonsil surgery anesthesia: Effect on recovery time of respiration and consciousness in paediatric patients. Tropical Journal of Pharmaceutical Research, 22(5), 1073-1079. https://doi.org/10.4314/tjpr.v22i5.20
citation: Interlandi C, Di Pietro S, Costa GL, Spadola F, Iannelli NM, Macri D, Ferrantelli V, Macri F. Effects of Cisatracurium in Sevoflurane and Propofol Requirements in Dog-Undergoing-Mastectomy Surgery. Animals (Basel). 2022 Nov 14;12(22):3134. doi: 10.3390/ani12223134.
citation: Liu J, Yang L. Effects of propofol and sevoflurane on blood glucose, hemodynamics, and inflammatory factors of patients with type 2 diabetes mellitus and gastric cancer. Oncol Lett. 2020 Feb;19(2):1187-1194. doi: 10.3892/ol.2019.11201. Epub 2019 Dec 10.
citation: ALKAYA SOLMAZ, F., & KIRDEMİR, P. (2020, March 2). Enhanced recovery after surgery (ERAS) and anesthesia. Acta Medica Alanya, 4(1), 95-101. https://doi.org/10.30565/medalanya.587027
citation: Bennett J, McDonald T, Lieblich S, Piecuch J. Perioperative rehydration in ambulatory anesthesia for dentoalveolar surgery. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1999 Sep;88(3):279-84. doi: 10.1016/s1079-2104(99)70028-4.
citation: Pollard BJ, Bryan A, Bennett D, Faragher EB, Un EN, Keegan M, Wilson A, Burkill M, Beatty PC, Stollery BT, et al. Recovery after oral surgery with halothane, enflurane, isoflurane or propofol anaesthesia. Br J Anaesth. 1994 May;72(5):559-66. doi: 10.1093/bja/72.5.559.
citation: Asakura A, Mihara T, Goto T. The Effect of Preoperative Oral Carbohydrate or Oral Rehydration Solution on Postoperative Quality of Recovery: A Randomized, Controlled Clinical Trial. PLoS One. 2015 Aug 28;10(8):e0133309. doi: 10.1371/journal.pone.0133309. eCollection 2015.
citation: Pocock SJ. Clinical Trials: A Practical Approach. Wiley; in 1983
citation: Faul F, Erdfelder E, Buchner A, Lang AG. Statistical power analyses using G*Power 3.1: tests for correlation and regression analyses. Behav Res Methods. 2009 Nov;41(4):1149-60. doi: 10.3758/BRM.41.4.1149.