Effect of Opioid Free Versus Opioid-Based Anesthesia on Cerebral Oximetry In Gastric Sleeve Operation

NCT05146232 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-02-01

No results posted yet for this study

Summary

Obesity and pneumoperitoneum in the reverse-Trendelenburg position during laparoscopic sleeve gastrectomy (LSG) are reported to negatively affect cerebral oxygenation. Anesthetic agents can have variable effects on the regional cerebral tissue oxygen saturation (rSO2) measured with near-infrared spectroscopy. This study investigated the potential impact of opioid free versus opioid based anesthesia on rSO2 in LSG cases. 80 American Society of Anesthesiologists (ASA) II-III patients, 18-65 years of age, with a body mass index of \>35 kg/m2 , undergoing LSG were randomized to two groups: opioid free and opioid based groups for anesthesia maintenance. The rSO2 values were recorded preoperatively, 1 min after anesthesia induction, and every 5 min during surgery. Arterial blood gases (ABG) were measured in the fifth minute postinduction (t1), 30th minute postinsuflation (t2), and postextubation (t3), and correlation with rSO2 .

Conditions

  • Bariatric Surgery Candidate

Interventions

OTHER

induction of anesthesia

induction of anesthesia during gastric sleeve surgery

OTHER

maintainance of anesthesia

maintainance of anesthesia during gastric sleeve surgery either opioid free or opioid based

OTHER

monitoring

electrocardiogram, noninvasive blood pressure, SpO2, rSO2 (Masimo oximeter), and neuromuscular monitoring (TOF-Watch SX; Organon, Dublin, Ireland) were performed on the patients.

OTHER

First postoperative analgesia

IV acetaminophen will be administered every 6 h

OTHER

Second postoperative analgesia

50 mg IV dexketoprofen every 8 h for the first 48 h.

Sponsors & Collaborators

  • Tanta University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-05
Primary Completion
2022-03-30
Completion
2022-03-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05146232 on ClinicalTrials.gov