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

T

Tanta University

Status and phase

Not yet enrolling
Phase 4

Conditions

Hypoventilation
Bariatric Surgery
Opioid Use
Anesthesia

Treatments

Drug: Opioid-sparing based anesthesia
Drug: Sevoflurane-based anesthesia

Study type

Interventional

Funder types

Other

Identifiers

NCT05962671
36264MS154/4/23

Details and patient eligibility

About

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.

Full 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.

Enrollment

72 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

72 participants in 2 patient groups

Opioid-sparing based anesthesia
Active Comparator group
Description:
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.
Treatment:
Drug: Opioid-sparing based anesthesia
Sevoflurane-based anesthesia
Active Comparator group
Description:
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%.
Treatment:
Drug: Sevoflurane-based anesthesia

Trial contacts and locations

1

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Central trial contact

Samah M Marie, MBBCh

Data sourced from clinicaltrials.gov

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