Clinical trial NCT05951686: The Effect of Anesthetic Methods on Gastrointestinal Motility
Official title: The Effect of Two Different Anesthetic Methods on Gastrointestinal Motility in Patients Scheduled for Laparoscopic Sleeve Gastrectomy: a Prospective, Randomized, Single Blinded Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Total Intravenous Anesthesia
Keywords: gastric motility
laparoscopic sleeve gastrectomy
desflurane
propofol
remifentanil
peristalsis
Lead sponsor: Bozyaka Training and Research Hospital
Sponsor class: OTHER
First posted: 2023-07-19
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this randomized controlled single blinded study is to compare the effect of the type of anesthesia on gastrointestinal motility in patients scheduled for laparoscopic sleeve gastrectomy. The main question it aims to answer is how do inhalation anesthesia and total intravenous anesthesia effect the gastrointestinal peristalsis during anastomosis.

Participants will be American Society of Anesthesiology (ASA) physical status II and III, between 18- 60 ages.

Researchers will compare inhalation anesthesia where desflurane is used with total intravenous anesthesia to see if the gastrointestinal motility differs between the groups.

Detailed description: Aim of this study is to evaluate the effect of two anesthetic methods on gastric motility during laparoscopic sleeve gastrectomy. Patients scheduled for laparoscopic sleeve gastrectomy with American Society of Anesthesiology (ASA) physical status II and III will enrolled into two groups. Computer based randomization will be used for the group selection. Patients will be monitored with standard monitorization (peripheral oxygen saturation, non-invasive blood pressure, 3-lead electrocardiography and patient state index (PSI)). Preoxygenation will be performed via a face mask with 6 L/min oxygen for 5 minutes. All patients will receive intravenous 2 mg/kg propofol, 0.25 mcg/kg/min remifentanil for anesthesia induction. Rocuronium bromide will be used intravenously with a dose of 0.6 mg/kg for muscle relaxation. Endotracheal intubation will be performed. In Group 1, inhalation anesthetic, desflurane and in Group 2, propofol infusion will be used with a 2 L/ min fresh gas flow as a mixture of 50 %- 50 % oxygen- medical air for maintenance of general anesthesia. Remifentanil infusion with a dose of 0.05-2 mcg/kg/min will be used in both groups during anesthesia maintenance. Anesthesia depth will be monitored with EEG monitorization where a score of 25-50 will be achieved in PSI . End-tidal carbon dioxide pressure will be kept between 35 and 45 mmHg. End-expiratory positive pressure will be set to 8 mmHg and intraabdominal pressure will be set to 12 mmHg. The surgeon will assess the gastric motility during anastomosis. The peristalsis during 1 minute period will be counted. 1 gram paracetamol and 1 mg/kg tramadol will be given intravenously for pain management. Sugammadex will be used for the reversal of neuromuscular blockade. Postoperative nause and vomiting, the time of first fart will be noted. Surgeon's satisfaction during anastomosis will be assessed with 5 points Likert Scale. Data will be statistically analyzed.

Eligibility criteria: Inclusion Criteria:

* 18-60 ages
* ASA II-III
* Patients scheduled for elective laparoscopic sleeve gastrectomy
* Body mass index 35 kg m2 and over

Exclusion Criteria:

* Hepatic disease
* Kidney disease
* Congestive heart disease
* Diabetes mellitus
* Neurological deficit
* Psychiatric disease
* Pregnancy
* Delayed gastric empting
* Previous bariatric surgery
* Patient's refusal
* Open surgery

Primary outcomes:
measure: Gastrointestinal motility
timeFrame: during surgery
Secondary outcomes:
measure: Fart
timeFrame: up to 24 hours after surgery
measure: Nause and vomiting
timeFrame: up to 24 hours after surgery
measure: Satisfaction of surgeon
timeFrame: during surgery
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Izmir Bozyaka Training and Research Hospital
state: Bozyaka
Study officials:
affiliation: Izmir Bozyaka Education and Research Hospital
name: Halide H Şahinkaya, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Izmir Bozyaka Education and Research Hospital
name: Ahmet M Öztürk, MD
role: STUDY_CHAIR
affiliation: Izmir Bozyaka Education and Research Hospital
name: Çağlar Ayar, MD
role: STUDY_CHAIR
affiliation: Izmir Bozyaka Education and Research Hospital
name: Hüseyin Özkarakaş, MD
role: STUDY_CHAIR
affiliation: Izmir Bozyaka Education and Research Hospital
name: Bülent Çalık, Ass. Prof
role: STUDY_CHAIR
affiliation: Izmir Bozyaka Education and Research Hospital
name: Zeki T Tekgül, Ass. Prof.
role: STUDY_CHAIR
References:
citation: Akkurt BC, Temiz M, Inanoglu K, Aslan A, Turhanoglu S, Asfuroglu Z, Canbolant E. Comparison of recovery characteristics, postoperative nausea and vomiting, and gastrointestinal motility with total intravenous anesthesia with propofol versus inhalation anesthesia with desflurane for laparoscopic cholecystectomy: A randomized controlled study. Curr Ther Res Clin Exp. 2009 Apr;70(2):94-103. doi: 10.1016/j.curtheres.2009.04.002.
citation: Liao Q, Wang MA, Ouyang W. [Effect of different anesthesias on gastrointestinal motility after laparoscopic cholecystectomy]. Hunan Yi Ke Da Xue Xue Bao. 2003 Feb 28;28(1):73-5. Chinese.
citation: De Corte W, Delrue H, Vanfleteren LJ, Dutre PE, Pottel H, Devriendt DK, Van Rooy FH, D'Hondt M, Carlier S, Desmet MB. Randomized clinical trial on the influence of anaesthesia protocol on intestinal motility during laparoscopic surgery requiring small bowel anastomosis. Br J Surg. 2012 Nov;99(11):1524-9. doi: 10.1002/bjs.8883. Epub 2012 Sep 21.