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

Phase 4

Not yet recruiting

• Conditions: Anesthesia; Hypoventilation; Opioid Use; Bariatric Surgery
• Interventions: Drug: Opioid-sparing based anesthesia; Drug: Sevoflurane-based anesthesia

• Registration Number: NCT05962671
• Lead Sponsor: Tanta University

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.

Detailed Description

The incidence of early postoperative hypoxemia in the literature is diverse, this may be due to multivariable, including patient-related factors, anesthesia-related factors, and surgery-related factors. Because of the controverse regarding the incidence of postoperative hypoxemia and the evidence of anesthetic technique of choice, interest in prevention and early management of early postoperative hypoxemia after laparoscopic bariatric surgery is continued.

Study Timeline

• Study First Submitted: 2023-06-24
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-26
• Last Update Submitted: 2023-07-26
• Study First Posted: 2023-07-27
• Last Update Posted: 2023-07-27
• Study Start: 2023-08-10
• Primary Completion: 2024-03-30
• Study Completion: 2024-03-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Opioid-sparing based anesthesia	Opioid-sparing based anesthesia	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.
Sevoflurane-based anesthesia	Sevoflurane-based anesthesia	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%.

Primary Outcome Measures

Name	Time	Method
Incidence of Early postoperative hypoventilation	UP to 24 hours Postoperatively	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.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt