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

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

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90 participants in 2 patient groups, including a placebo group

Sugammadex

Active Comparator group

Treatment:

Drug: Sugammadex

Neostigmine

Placebo Comparator group

Treatment:

Drug: Neostigmine