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

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ClinicalTrials.gov Identifier: NCT04570150
Recruitment Status : Recruiting
First Posted : September 30, 2020
Last Update Posted : November 3, 2020
Sponsor:
Information provided by (Responsible Party):
Jerry Ingrande, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
Anesthesia Drug: Sugammadex Drug: Neostigmine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Optimizing Post-operative Recovery in Bariatric Patients With Obstructive Sleep Apnea Undergoing Outpatient Surgery: A Comparison of Sugammadex and Neostigmine
Estimated Study Start Date : January 1, 2021
Estimated Primary Completion Date : May 1, 2022
Estimated Study Completion Date : August 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Active Comparator: Sugammadex Drug: 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).

Placebo Comparator: Neostigmine 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).




Primary Outcome Measures :
  1. Time to recover of train of four ratio >0.9 [ Time Frame: measured in OR immediately after sugammadex or neostigmine is administered ]
    time to recover from neuromuscular block

  2. Time to PACU discharge [ 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 ]
    Time it takes from admittance to discharge from PACU


Secondary Outcome Measures :
  1. Compare pre- and postoperative changes in peak expiratory flow (PEF) [ 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 ]
    Compare peak expiratory flow (PEF) after sugammadex or neostigmine reversal

  2. Compare pre- and postoperative changes in forced expiratory volume (FEV1) [ 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 ]
    Compare forced expiratory volume (FEV1) after sugammadex or neostigmine reversal

  3. Compare pre- and postoperative changes in forced vital capacity (FVC) [ 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 ]
    Compare forced vital capacity (FVC) after sugammadex or neostigmine reversal

  4. Compare pre- and post-operative arterial blood gas values (PaO2) [ 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 ]
    Measure and compare PaO2 levels in subjects who received sugammadex or neostigmine for reversal of neuromuscular block

  5. Compare pre- and post-operative arterial blood gas values (PaCO2) [ 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 ]
    Measure and compare PaCO2 levels in subjects who received sugammadex or neostigmine for reversal of neuromuscular block



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04570150


Contacts
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Contact: Jerry Ingrande, M.D. 619-543-5560 jingrande@health.ucsd.edu
Contact: Rodney Gabriel, M.D. 619-543-5560 ragabriel@health.ucsd.edu

Locations
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United States, California
University of California San Diego Recruiting
La Jolla, California, United States, 92037
Contact: Jerry Ingrande, M.D.    619-543-5560    jingrande@health.ucsd.edu   
Sponsors and Collaborators
University of California, San Diego
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Responsible Party: Jerry Ingrande, Associate Clinical Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT04570150    
Other Study ID Numbers: MISP 59701
First Posted: September 30, 2020    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Neostigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents