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The Effect of Anesthetic Methods on Gastrointestinal Motility

B

Bozyaka Training and Research Hospital

Status

Completed

Conditions

Total Intravenous Anesthesia
Anesthesia

Treatments

Other: Fresh gas
Drug: Propofol infusion
Drug: Remifentanil infusion
Drug: Desflurane

Study type

Interventional

Funder types

Other

Identifiers

NCT05951686
HandeBariatric

Details and patient eligibility

About

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.

Full 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.

Enrollment

61 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

61 participants in 2 patient groups

Group inhalation
Active Comparator group
Description:
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.
Treatment:
Drug: Desflurane
Drug: Remifentanil infusion
Other: Fresh gas
Group tiva
Active Comparator group
Description:
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.
Treatment:
Drug: Remifentanil infusion
Drug: Propofol infusion
Other: Fresh gas

Trial contacts and locations

1

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Central trial contact

Halide H Şahinkaya, MD; Zeki T Tekgül, Ass. Prof.

Data sourced from clinicaltrials.gov

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