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

NCT05146232 | Unknown

• 1 other identifier: 34777/7/21
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Changes of regional cerebral oxygen saturation percentage

  Measred noninvasively by electrodes of Masimo oximeter on all patient' forehead before induction of anesthesia

  Measured preoperatively, 1 minute after the induction, and every 5 minutes until the patient will be referred to the recovery unit.

Study Arms (2)

Opioid free group

ACTIVE COMPARATOR

After induction of aesthesia, anesthesia maintained by sevoflurane and continuous unfusion of lidocaine, ketamine, dexmeditomedine and Paracetamol.

Other: induction of anesthesia; Other: maintainance of anesthesia; Other: monitoring; Other: First postoperative analgesia; Other: Second postoperative analgesia

Opioid based group

ACTIVE COMPARATOR

After induction of aesthesia, anesthesia maintained by continuous remifentanyl infusion

Other: induction of anesthesia; Other: maintainance of anesthesia; Other: monitoring; Other: First postoperative analgesia; Other: Second postoperative analgesia

Interventions

induction of anesthesia OTHER

induction of anesthesia during gastric sleeve surgery

Opioid based group; Opioid free group

maintainance of anesthesia OTHER

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

Opioid based group; Opioid free group

monitoring OTHER

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

Opioid based group; Opioid free group

First postoperative analgesia OTHER

IV acetaminophen will be administered every 6 h

Opioid based group; Opioid free group

Second postoperative analgesia OTHER

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

Opioid based group; Opioid free group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASAphysical status class II-III
• Patients undergoing laparoscopic sleeve

You may not qualify if:

• neurolgical diseases
• cardiovascular diseases

Sponsors & Collaborators

• Tanta University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The anesthesiologist caring for the patient will be aware of the group assignments.While the person who is responsible for patient monitor recording and the patients will be blinded to the group assignments.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: The rSO2 values will be recorded preoperatively, 1 min after anesthesia induction, and every 5 min during surgery. Arterial blood gases (ABG) will be measured in the fifth minute postinduction (t1), 30th minute postinsufflation (t2), and postextubation (t3), and correlation with rSO2 will be examined.

Study Record Dates

• First Submitted: November 6, 2021
• First Posted: December 6, 2021
• Study Start: February 5, 2022
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: February 1, 2022

Record last verified: 2021-12