The Effect of Anesthetic Methods on Gastrointestinal Motility

Anesthesia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05951686
• Other study ID #: HandeBariatric
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2023
• Source: Bozyaka Training and Research Hospital
• Contact: Halide H Sahinkaya, MD
• Phone: +905058892157
• Email: drhhande[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: August 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Total Intravenous Anesthesia

Intervention

Drug:
• Desflurane
In inhalation group, desflurane will be used for general anesthesia maintenance under the screening with Patient State Index (PSI) between a score of 25-50. Remifentanil infusion is used with desflurane with a dose of 0.05-2 mcg/ kg/ min according to PSI . Fresh gas flow is used 2 L/ min with a mixture of 50%- 50% oxygen and medical air in both groups.
• Remifentanil infusion
Remifentanil infusion will be used with a dose of 0.05-2 mcg/ kg/ min under the screening with Patient State Index (PSI) between a score of 25-50 in both groups.

Other:
• Fresh gas
Fresh gas flow will be used 2 L/ min with a mixture of 50%- 50% oxygen and medical air in both groups.

Drug:
• Propofol infusion
Propofol infusion will be used for general anesthesia maintenance with a dose of under the screening of Patient State Index (PSI) between a score of 25-50 in group tiva.

Locations

Country	Name	City	State
Turkey	Izmir Bozyaka Training and Research Hospital	Izmir	Bozyaka

Sponsors (1)

Lead Sponsor	Collaborator
Bozyaka Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastrointestinal motility	Gastrointestinal motility is the number of peristalsis during a one minute period. The surgeon will be asked to count the number of peristalsis during surgical anastomosis in a one minute period.	during surgery
Secondary	Fart	The time of first fart	up to 24 hours after surgery
Secondary	Nause and vomiting	Incidence of postoperative nause and vomiting	up to 24 hours after surgery
Secondary	Satisfaction of surgeon	Ease of anastomosis and satisfaction of surgeon will be measured with 5 point Likert Scale as 1: very dissatisfied, 2:dissatisfied, 3: neither dissatisfied or satisfied, 4: satisfied, 5: very satisfied	during surgery