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

Opioid-sparing Versus Sevoflurane-based Anesthesia on Early Postoperative Hypoventilation in Patients Undergoing Laparoscopic Bariatric Surgery: Prospective Randomized Study

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05962671

Enrollment

Registered

2023-07-27

Start date

2023-08-10

Completion date

2024-03-30

Last updated

2023-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Bariatric Surgery, Hypoventilation, Opioid Use

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.

Interventions

DRUGOpioid-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.

DRUGSevoflurane-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%.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Egypt

Contacts

Primary ContactSamah M Marie, MBBCh

mohamedsamah084@gmail.com+20 120 745 203

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026