The Effect of Anesthetic Methods on Gastrointestinal Motility

NCT05951686 | Completed DMC

• 1 other identifier: HandeBariatric
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Total Intravenous Anesthesia

Keywords

gastric motility; laparoscopic sleeve gastrectomy; desflurane; propofol; remifentanil; peristalsis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Fart

  up to 24 hours after surgery

• Nause and vomiting

  up to 24 hours after surgery

• Satisfaction of surgeon

  during surgery

Study Arms (2)

Group inhalation

ACTIVE COMPARATOR

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.

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

Group tiva

ACTIVE COMPARATOR

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.

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

Interventions

Desflurane DRUG

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.

Also known as: suprane

Group inhalation

Remifentanil infusion DRUG

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.

Also known as: ultiva

Group inhalation; Group tiva

Fresh gas OTHER

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

Group inhalation; Group tiva

Propofol infusion DRUG

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.

Also known as: propofol 2%

Group tiva

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bozyaka Training and Research Hospital: lead

Study Sites (1)

Izmir Bozyaka Training and Research Hospital

Izmir, Bozyaka, Turkey (Türkiye)

Location

Related 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.

  PMID: 24683221 BACKGROUND

• 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.

  PMID: 12934407 BACKGROUND

• 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.

  PMID: 23001752 BACKGROUND

MeSH Terms

Interventions

Desflurane; Remifentanil

Intervention Hierarchy (Ancestors)

Ethyl Ethers; Ethers; Organic Chemicals; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Halide H Şahinkaya, MD

  Izmir Bozyaka Education and Research Hospital

  PRINCIPAL INVESTIGATOR

• Ahmet M Öztürk, MD

  Izmir Bozyaka Education and Research Hospital

  STUDY CHAIR

• Çağlar Ayar, MD

  Izmir Bozyaka Education and Research Hospital

  STUDY CHAIR

• Hüseyin Özkarakaş, MD

  Izmir Bozyaka Education and Research Hospital

  STUDY CHAIR

• Bülent Çalık, Ass. Prof

  Izmir Bozyaka Education and Research Hospital

  STUDY CHAIR

• Zeki T Tekgül, Ass. Prof.

  Izmir Bozyaka Education and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Anesthesiology Specialist

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: July 19, 2023
• Study Start: August 15, 2022
• Primary Completion: October 15, 2023
• Study Completion: December 31, 2023
• Last Updated: August 13, 2024

Record last verified: 2024-08

Locations

TU (1)