Clinical trial NCT05822817: Comparison of Postoperative Recovery of Sevoflurane and Propofol After Transsphenoidal Surgery
Official title: A Prospective, Randomized Controlled Study to Compare the Effect of Sevoflurane and Propofol for Maintenance of Anesthesia on Postoperative Recovery After Transsphenoidal Resection of Pituitary Adenoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pituitary Adenoma
Keywords: Anesthesia
Transsphenoidal surgery
Enhanced recovery after surgery
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-04-21
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Currently, total intravenous anesthesia (TIVA) and inhaled anesthesia are both commonly used for transsphenoidal pituitary adenoma resection. However, optimal choice for anesthesia maintenance in transsphenoidal surgery remains unclear. Previous studies focusing on this question provided fragmentary assessment and controversial results. The goal of this clinical trial is to investigate whether propofol and sevoflurane have different effect on post-anesthetic recovery after transsphenoidal resection of pituitary adenoma.


Eligibility criteria: Inclusion Criteria:

1. Men or women, aged from 18 to 70
2. American Society of Anesthesiologists (ASA) class I - III
3. Patients scheduled for transsphenoidal surgery requiring general anesthesia managed with endotracheal intubation

Exclusion Criteria:

1. Patients allergic or contraindicated to sevoflurane, propofol, or other drugs used during surgery
2. Severe pulmonary disease, saturation of peripheral oxygen (SpO2) \< 90%
3. Severe nervous system disease with consciousness disorder
4. Patients scheduled for intensive care unit (ICU) after surgery
5. Pregnancy

Primary outcomes:
measure: 15-item quality of recovery score (QoR-15)
timeFrame: 24 hours after end of surgery
Secondary outcomes:
measure: Time to awake from anesthesia
timeFrame: From stopping sevoflurane or propofol to awake, approximately 30 minutes
measure: Time to extubation
timeFrame: From stopping sevoflurane or propofol to recovery of spontaneous breathing and withdrawal of tracheal tube, approximately 30 minutes
measure: Agitation or sedation level during emergence
timeFrame: From stopping sevoflurane or propofol to complete awakening, approximately 30 minutes
measure: Coughing and bucking during emergence
timeFrame: From stopping sevoflurane or propofol to complete awakening, approximately 30 minutes
measure: Time to discharge from postanesthesia care unit (PACU)
timeFrame: From admit into PACU to discharge from PACU, approximately 45 minutes
measure: PACU antiemetic drug use
timeFrame: From admit into PACU to discharge from PACU, approximately 45 minutes
measure: PACU analgesic drug use
timeFrame: From admit into PACU to discharge from PACU, approximately 45 minutes
measure: Post operative nausea and vomiting score
timeFrame: 24 hours after end of surgery
measure: Concentration of serum adrenocorticotropic hormone (ACTH)
timeFrame: 24 hours after end of surgery
measure: Concentration of serum cortisol
timeFrame: 24 hours after end of surgery
measure: Concentration of serum thyroid-stimulating hormone (TSH)
timeFrame: 24 hours after end of surgery
measure: Concentration of serum growth hormone (GH)
timeFrame: 24 hours after end of surgery
measure: Concentration of serum gonadotrophin
timeFrame: 24 hours after end of surgery
measure: Concentration of serum prolactin (PRL)
timeFrame: 24 hours after end of surgery
measure: Counts of peripheral blood lymphocyte
timeFrame: 24 hours after end of surgery
measure: Incidence of hypotension during anesthesia
timeFrame: From start of surgery to end of surgery, on an average of 2 hours
measure: Incidence of hypertension during anesthesia
timeFrame: From start of surgery to end of surgery, on an average of 2 hours
measure: Time to discharge from hospital
timeFrame: From end of surgery to discharge from hospital, on an average of 2 days
Other outcomes:
measure: Number of participants with postoperative complications
timeFrame: After the surgery till discharge
measure: Number of participants with postoperative complications
timeFrame: After discharge till 7 days after the surgery
measure: Numerical rating scale (NRS) pain score at postoperative day 7
timeFrame: 7 days after the surgery
measure: Post operative nausea and vomiting score at postoperative day 7
timeFrame: 7 days after the surgery
measure: Sleep quality score at postoperative day 7
timeFrame: 7 days after the surgery
measure: Appetite score at postoperative day 7
timeFrame: 7 days after the surgery
measure: 30-day readmission
timeFrame: At the 1st postoperative month
measure: Concentration of serum cortisol
timeFrame: At the 3rd postoperative month
measure: Concentration of serum growth hormone (GH)
timeFrame: At the 3rd postoperative month
measure: Concentration of serum gonadotrophin
timeFrame: At the 3rd postoperative month
measure: Concentration of serum thyroid-stimulating hormone (TSH)
timeFrame: At the 3rd postoperative month
measure: Concentration of serum prolactin (PRL)
timeFrame: At the 3rd postoperative month
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Department of Anesthesiology, Peking Union Medical College Hospital
name: Yuguang Huang, MD
role: STUDY_CHAIR
affiliation: Department of Anesthesiology, Peking Union Medical College Hospital
name: Lulu Ma, MD
role: STUDY_DIRECTOR
affiliation: Department of Neurosurgery, Peking Union Medical College Hospital
name: Bing Xing, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Neurosurgery, Peking Union Medical College Hospital
name: Wei Lian, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cafiero T, Cavallo LM, Frangiosa A, Burrelli R, Gargiulo G, Cappabianca P, de Divitiis E. Clinical comparison of remifentanil-sevoflurane vs. remifentanil-propofol for endoscopic endonasal transphenoidal surgery. Eur J Anaesthesiol. 2007 May;24(5):441-6. doi: 10.1017/S0265021506002080. Epub 2007 Mar 12.
citation: Ali Z, Prabhakar H, Bithal PK, Dash HH. Bispectral index-guided administration of anesthesia for transsphenoidal resection of pituitary tumors: a comparison of 3 anesthetic techniques. J Neurosurg Anesthesiol. 2009 Jan;21(1):10-5. doi: 10.1097/ANA.0b013e3181855732.
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.