Optimizing Post-operative Recovery in Bariatric Patients With Obstructive Sleep Apnea Undergoing Outpatient Surgery: A Comparison of Sugammadex and Neostigmine

University of California San Diego logo

University of California San Diego

Status and phase

Completed
Phase 4

Conditions

Anesthesia

Treatments

Drug: Neostigmine
Drug: Sugammadex

Study type

Interventional

Funder types

Other

Identifiers

NCT04570150
MISP 59701

Details and patient eligibility

About

This study assesses the efficacy of sugammadex against neostigmine for hastening recovery from neuromuscular blockade and optimizing pulmonary function in obese patients with obstructive sleep apnea presenting for outpatient surgery. Both drugs are used in anesthesiology to reverse neuromuscular blockade that is given in the setting of inducing and maintaining general anesthesia.

Enrollment

90 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • obese (body mass index [BMI] >30 kg/m2)
  • diagnosis of obstructive sleep apnea (OSA) (with or without continuous positive airway pressure [CPAP] use)
  • scheduled for surgery requiring general anesthesia and neuromuscular blockade

Exclusion criteria

  • history of hepatic, renal, or cardiovascular and/or cerebrovascular dysfunction
  • history of difficult tracheal intubation
  • history of adverse reaction to anesthesia
  • history of adverse reaction to rocuronium, sugammadex, and/or neostigmine/glycopyrrolate

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

90 participants in 2 patient groups, including a placebo group

Sugammadex
Active Comparator group
Treatment:
Drug: Sugammadex
Neostigmine
Placebo Comparator group
Treatment:
Drug: Neostigmine

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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