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

• Sponsor: University of California, San Diego (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04570150
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 32
• Patients Per Site Per Month: 3.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Drug: Sugammadex; Drug: Neostigmine	Phase 4

Study Design

• Study Type: Interventional
• Anticipated 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
• Actual Study Start Date: Jan 4, 2021
• Anticipated Primary Completion Date: Jan 4, 2023
• Anticipated Study Completion Date: Sep 4, 2023

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

1. Time to recover of train of four ratio >0.9 [measured in OR immediately after sugammadex or neostigmine is administered]

   time to recover from neuromuscular block

2. Time to PACU discharge [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) [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) [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) [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) [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) [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California San Diego	La Jolla	California	United States	92037

Sponsors and Collaborators

• University of California, San Diego

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jerry Ingrande, Associate Clinical Professor, University of California, San Diego
• ClinicalTrials.gov Identifier: NCT04570150
• Other Study ID Numbers: MISP 59701
• First Posted: Sep 30, 2020
• Last Update Posted: May 5, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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: Sleep Apnea, Obstructive; Neostigmine

Study Results

No Results Posted as of May 5, 2022