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

NCT ID: NCT04570150

Last Updated: 2024-04-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-04

Study Completion Date

2024-01-04

Brief Summary

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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.

Detailed Description

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Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Sugammadex

Group Type ACTIVE_COMPARATOR

Sugammadex

Intervention Type DRUG

Subjects who are randomized to into the sugammadex arm (Arm I) will receive sugammadex for reversal of neuromuscular block at the completion of their anesthetic; Outcomes measures will be recorded and compared with those from Arm II (neostigmine group).

Neostigmine

Group Type PLACEBO_COMPARATOR

Neostigmine

Intervention Type DRUG

Subjects who are randomized into the neostigmine arm (Arm II) will receive neostigmine for reversal of neuromuscular block at the completion of their anesthetic; Outcomes measures will be recorded and compared with those from Arm I (sugammadex group).

Interventions

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Sugammadex

Subjects who are randomized to into the sugammadex arm (Arm I) will receive sugammadex for reversal of neuromuscular block at the completion of their anesthetic; Outcomes measures will be recorded and compared with those from Arm II (neostigmine group).

Intervention Type DRUG

Neostigmine

Subjects who are randomized into the neostigmine arm (Arm II) will receive neostigmine for reversal of neuromuscular block at the completion of their anesthetic; Outcomes measures will be recorded and compared with those from Arm I (sugammadex group).

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Jerry Ingrande

Associate Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of California San Diego

La Jolla, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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MISP 59701

Identifier Type: -

Identifier Source: org_study_id

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