search
Back to results

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

Primary Purpose

Anesthesia

Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Sugammadex
Neostigmine
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Anesthesia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of California San Diego

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Sugammadex

Neostigmine

Arm Description

Outcomes

Primary Outcome Measures

Time to recover of train of four ratio >0.9
time to recover from neuromuscular block
Time to PACU discharge
Time it takes from admittance to discharge from PACU

Secondary Outcome Measures

Compare pre- and postoperative changes in peak expiratory flow (PEF)
Compare peak expiratory flow (PEF) after sugammadex or neostigmine reversal
Compare pre- and postoperative changes in forced expiratory volume (FEV1)
Compare forced expiratory volume (FEV1) after sugammadex or neostigmine reversal
Compare pre- and postoperative changes in forced vital capacity (FVC)
Compare forced vital capacity (FVC) after sugammadex or neostigmine reversal
Compare pre- and post-operative arterial blood gas values (PaO2)
Measure and compare PaO2 levels in subjects who received sugammadex or neostigmine for reversal of neuromuscular block
Compare pre- and post-operative arterial blood gas values (PaCO2)
Measure and compare PaCO2 levels in subjects who received sugammadex or neostigmine for reversal of neuromuscular block

Full Information

First Posted
September 17, 2020
Last Updated
May 8, 2023
Sponsor
University of California, San Diego
search

1. Study Identification

Unique Protocol Identification Number
NCT04570150
Brief Title
Optimizing Post-operative Recovery in Bariatric Patients With Obstructive Sleep Apnea Undergoing Outpatient Surgery: A Comparison of Sugammadex and Neostigmine
Official Title
Optimizing Post-operative Recovery in Bariatric Patients With Obstructive Sleep Apnea Undergoing Outpatient Surgery: A Comparison of Sugammadex and Neostigmine
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 4, 2021 (Actual)
Primary Completion Date
January 4, 2023 (Actual)
Study Completion Date
January 4, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sugammadex
Arm Type
Active Comparator
Arm Title
Neostigmine
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Sugammadex
Intervention Description
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
Intervention Name(s)
Neostigmine
Intervention Description
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).
Primary Outcome Measure Information:
Title
Time to recover of train of four ratio >0.9
Description
time to recover from neuromuscular block
Time Frame
measured in OR immediately after sugammadex or neostigmine is administered
Title
Time to PACU discharge
Description
Time it takes from admittance to discharge from PACU
Time Frame
Time to PACU discharge will begin at the time each subject is admitted to the PACU following surgery. The time will end immediately once the subject physically leaves the PACU. The outcome will be measured for each subject on their day of surgery
Secondary Outcome Measure Information:
Title
Compare pre- and postoperative changes in peak expiratory flow (PEF)
Description
Compare peak expiratory flow (PEF) after sugammadex or neostigmine reversal
Time Frame
Pre-operative peak expiratory flow (PEF) will be measured 10 minutes prior to entry to the operating room; post-operative PEF will be measured 30 minutes after PACU admission
Title
Compare pre- and postoperative changes in forced expiratory volume (FEV1)
Description
Compare forced expiratory volume (FEV1) after sugammadex or neostigmine reversal
Time Frame
Pre-operative forced expiratory volume (FEV1) will be measured 10 minutes prior to entry to the operating room; post-operative FEV1 will be measured 30 minutes after PACU admission
Title
Compare pre- and postoperative changes in forced vital capacity (FVC)
Description
Compare forced vital capacity (FVC) after sugammadex or neostigmine reversal
Time Frame
Pre-operative forced vital capacity (FVC) will be measured 10 minutes prior to entry to the operating room; post-operative FVC will be measured 30 minutes after PACU admission
Title
Compare pre- and post-operative arterial blood gas values (PaO2)
Description
Measure and compare PaO2 levels in subjects who received sugammadex or neostigmine for reversal of neuromuscular block
Time Frame
Pre-operative PaO2 arterial blood gas measurements will be measured 10 minutes prior to entry to the operating room; post-operative PaO2 arterial blood gas measurements will be measured 30 minutes after PACU admission
Title
Compare pre- and post-operative arterial blood gas values (PaCO2)
Description
Measure and compare PaCO2 levels in subjects who received sugammadex or neostigmine for reversal of neuromuscular block
Time Frame
Pre-operative PaCO2 arterial blood gas measurements will be measured 10 minutes prior to entry to the operating room; post-operative PaCO2 arterial blood gas measurements will be measured 30 minutes after PACU admission

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs