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Clinical Trials/NCT05951686
NCT05951686
Completed
Not Applicable

The Effect of Two Different Anesthetic Methods on Gastrointestinal Motility in Patients Scheduled for Laparoscopic Sleeve Gastrectomy: a Prospective, Randomized, Single Blinded Clinical Trial

Bozyaka Training and Research Hospital1 site in 1 country61 target enrollmentAugust 15, 2022

Overview

Phase
Not Applicable
Intervention
Desflurane
Conditions
Anesthesia
Sponsor
Bozyaka Training and Research Hospital
Enrollment
61
Locations
1
Primary Endpoint
Gastrointestinal motility
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 15, 2022
End Date
December 31, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Bozyaka Training and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Halide Hande Şahinkaya

MD, Anesthesiology Specialist

Bozyaka Training and Research Hospital

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

Arms & Interventions

Group inhalation

Patients will receive desflurane as an inhalation anesthetic and remifentanil infusion for general anesthesia maintenance during the surgery. The doses of desflurane and remifentanil will be adjusted according to the Patient State Index (PSI) where the goal score is 25-50.

Intervention: Desflurane

Group inhalation

Patients will receive desflurane as an inhalation anesthetic and remifentanil infusion for general anesthesia maintenance during the surgery. The doses of desflurane and remifentanil will be adjusted according to the Patient State Index (PSI) where the goal score is 25-50.

Intervention: Remifentanil infusion

Group inhalation

Patients will receive desflurane as an inhalation anesthetic and remifentanil infusion for general anesthesia maintenance during the surgery. The doses of desflurane and remifentanil will be adjusted according to the Patient State Index (PSI) where the goal score is 25-50.

Intervention: Fresh gas

Group tiva

Patients will receive total intravenous anesthesia with an infusion of propofol and remifentanil for general anesthesia maintenance during the surgery. The infusion doses will be changed according to the Patient State Index (PSI) where the goal score is 25-50.

Intervention: Remifentanil infusion

Group tiva

Patients will receive total intravenous anesthesia with an infusion of propofol and remifentanil for general anesthesia maintenance during the surgery. The infusion doses will be changed according to the Patient State Index (PSI) where the goal score is 25-50.

Intervention: Fresh gas

Group tiva

Patients will receive total intravenous anesthesia with an infusion of propofol and remifentanil for general anesthesia maintenance during the surgery. The infusion doses will be changed according to the Patient State Index (PSI) where the goal score is 25-50.

Intervention: Propofol infusion

Outcomes

Primary Outcomes

Gastrointestinal motility

Time Frame: during surgery

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.

Secondary Outcomes

  • Nause and vomiting(up to 24 hours after surgery)
  • Satisfaction of surgeon(during surgery)
  • Fart(up to 24 hours after surgery)

Study Sites (1)

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