The Effect of Anesthetic Methods on Gastrointestinal Motility
- Conditions
- AnesthesiaTotal Intravenous Anesthesia
- Interventions
- Registration Number
- NCT05951686
- Lead Sponsor
- Bozyaka Training and Research Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 61
- 18-60 ages
- ASA II-III
- Patients scheduled for elective laparoscopic sleeve gastrectomy
- Body mass index 35 kg m2 and over
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group tiva Propofol infusion 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. Group tiva Remifentanil infusion 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. Group inhalation Remifentanil infusion 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. Group inhalation Fresh gas 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. Group tiva Fresh gas 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. Group inhalation Desflurane 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.
- Primary Outcome Measures
Name Time Method Gastrointestinal motility 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 Outcome Measures
Name Time Method Nause and vomiting up to 24 hours after surgery Incidence of postoperative nause and vomiting
Satisfaction of surgeon during surgery 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
Fart up to 24 hours after surgery The time of first fart
Trial Locations
- Locations (1)
Izmir Bozyaka Training and Research Hospital
🇹🇷İzmir, Bozyaka, Turkey