Opioid-sparing Versus Sevoflurane Anesthesia on Early Postoperative Hypoventilation in Laparoscopic Bariatric Surgery

NCT05962671 | Unknown Phase 4 DMC

• 1 other identifier: 36264MS154/4/23
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Determine the incidence of early post-operative hypoventilation in post-anesthesia care unit (PACU) in patients undergoing laparoscopic bariatric surgery under opioid-sparing compared with sevoflurane-based anesthesia.

Conditions

Anesthesia; Hypoventilation; Opioid Use; Bariatric Surgery

Outcome Measures

Primary Outcomes (1)

• Incidence of Early postoperative hypoventilation

  Early postoperative respiratory hypoventilation will be defined by any of the following parameters: Oxygen saturation \< 95% for 10 seconds. Respiratory rate \< 8 breath/min. Apnea spill \> 10 seconds. pain/sedation-mismatch.

  UP to 24 hours Postoperatively

Study Arms (2)

Opioid-sparing based anesthesia

ACTIVE COMPARATOR

Intraoperative opioid-sparing maintenance comprised dexmedetomidine bolus dose of 1 mcg/kg followed by 0.3 mcg/kg/h, propofol 4-8 mg/kg/h and ketamine 25 mg/h for a max of 50 mg during the procedure, targeting bispectral index (BIS) between 45%-60%. The lean body weight will be used for calculation of the drugs.

Drug: Opioid-sparing based anesthesia

Sevoflurane-based anesthesia

ACTIVE COMPARATOR

Intraoperative sevoflurane-based anesthesia, 0.8 to 1.0 Minimum alveolar concentration will be used combined with fentanyl 1 mcg/kg followed by 1 -2 mcg/kg/h and cis-atracurium, to keep bispectral index between 45% to 60%.

Drug: Sevoflurane-based anesthesia

Interventions

Opioid-sparing based anesthesia DRUG

Intraoperative opioid-sparing maintenance comprised dexmedetomidine bolus dose of 1 mcg/kg followed by 0.3 mcg/kg/h, propofol 4-8 mg/kg/h and ketamine 25 mg/h for a max of 50 mg during the procedure, targeting bispectral index (BIS) between 45%-60%. The lean body weight will be used for calculation of the drugs.

Also known as: Opioid

Opioid-sparing based anesthesia

Sevoflurane-based anesthesia DRUG

Intraoperative sevoflurane-based anesthesia, 0.8 to 1.0 Minimum alveolar concentration will be used combined with fentanyl 1 mcg/kg followed by 1 -2 mcg/kg/h and cis-atracurium, to keep bispectral index between 45% to 60%.

Also known as: Sevoflurane

Sevoflurane-based anesthesia

Eligibility Criteria

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

You may qualify if:

• All adult patients ≥ 18 years
• Admitted to the post anesthesia care unit after bariatric surgery

You may not qualify if:

• Preoperative hypoxemia which is determined by a peripheral capillary oxygen saturation (SPO2) reading of \< 90% on room air

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Conditions

Hypoventilation

Interventions

Analgesics, Opioid; Sevoflurane

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Central Study Contacts

Samah M Marie, MBBCh

CONTACT

+20 120 745 203; mohamedsamah084@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor resident of Anesthesiology, Surgical Intensive Care and Pain Medicine

Study Record Dates

• First Submitted: June 24, 2023
• First Posted: July 27, 2023
• Study Start: August 10, 2023
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: after the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author

Locations

EG (1)