Clinical trial NCT04570150
Conditions: Anesthesia
Sponsor: University of California, San Diego
Start date: 2021-01-04; Completion date: 2024-01-04
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Sugammadex intervention 2: Neostigmine
Intervention descriptions: intervention 1: 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 2: 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).

Protocol documents:
Prot_SAP_001.pdf: 
COVER SHEET 
 
 
Title:  Optimizing Post-operative Recovery in Bariatric Patients with 
Obstructive Sleep Apnea Following Outpatient Surgery: A 
Comparison of Sugammadex and Neostigmine  
 
NCT Number:   NCT 04570150 
 
Document Date:  11/30/2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
 
 
Methods: 
Subjects:  We will obtain approval from the Institutional Review Board at UCSD.  One hundred 
subjects will be enrolled in this study.  To be included in this study, subjects must be obese 
(body mass index [BMI] >30 kg/m2) with a concurrent diagnosis of OSA (with or without 
continuous positive airway pressure [CPAP] use), scheduled for surgery requiring general 
anesthesia and neuromuscular blockade at the UCSD Koman Outpatient Pavilion.  Subjects will 
be excluded from this study if they have a history of hepatic, renal, or cardiovascular and/or 
cerebrovascular dysfunction, history of difficult tracheal intubation, or adverse reaction to 
anesthesia.  Subjects with a known or suspected adverse reaction to rocuronium, sugammadex, 
and/or neostigmine/glycopyrrolate will also be excluded.  Subjects will be randomized to receive 
sugammadex (Group S), or neostigmine/glycopyrrolate (Group NG), for reversal of rocuronium-
induced neuromuscular block.   
Pre-anesthesia:  On the day of surgery, an 18 or 20G peripheral IV will be placed in the 
subjects upper extremity by the preoperative nurse prior to movement to the operating room.  
Prior to transport to the operating room, baseline spirometry measurements will be taken, along 
with an arterial blood gas measurement.  Baseline vital signs including heart rate, blood 
pressure, temperature, respiratory rate and pulse oximetry will be recorded. 
Induction and Maintenance of Anesthesia:  No pre-medications (including midazolam) will be 
administered.  We will position each subject on the operating table and administer 100% oxygen 
via face-mask.  We will apply standard monitors including EKG, non-invasive blood pressure, 
and pulse oximetry.  We will also record End-tidal CO2 measurements via capnography.  We 
will administer the following medications to each subject for induction of general anesthesia:  
fentanyl 3 mcg/kg LBW, propofol 2.5 mg/kg LBW, and succinylcholine 1 mg/kg TBW.  The 
trachea will be intubated and we will maintain anesthesia with an admixture of oxygen/air and 1-
1.2 MAC of sevoflurane.  We will use processed EEG to monitor depth of anesthesia.  
Rocuronium will be administered to achieve deep neuromuscular block (titrated to 0/4 twitches 
on train-of-four monitoring).   Each subject will receive odansetron 4 mg IV and dexamethasone 
8 mg IV for prevention of PONV.  
Reversal of Neuromuscular Block and emergence:  Ten minutes prior to planned extubation, 
subjects will be given sugammadex 2 mg/kg TBW (Group S) or neostigmine 0.07 mg/kg TBW 
and glycopyrrolate 0.2 mg for every 1 mg of neostigmine administered (Group NG), depending 
on pre-procedural randomization.  Reversal agents will be administered only after the Train-of 
Four ratio demonstrates the recovery of at least two twitches.  The reversal agents will be pre-
drawn so that the anesthesiologist in charge of care is blinded to both the reversal agent and 
subject randomization.  Five minutes following reversal of the neuromuscular block the 
remifentanil infusion will be discontinued. Extubation will occur once the subject has exhibited 
extubation criteria as deemed appropriate by standard of care guidelines (stable 
hemodynamics, stable respiratory mechanics, airway protection).  
Post-anesthesia Care:  Subjects will be brought to the post-anesthesia care unit (PACU) by 
the blinded anesthesiologist.  A second blinded assessor will record heart rate, blood pressure, 
temperature, pulse oximetry, observer-assessment sedation scores and subject subjective 
nausea and pain scores immediately upon PACU admission and every 20 minutes thereafter.  
Thirty minutes after PACU admission an arterial blood gas measurement will be taken, as well 
as spirometry measurements. The time to PACU discharge readiness will be recorded by a 
PACU nurse who will be blinded to subject randomization.  
 
 


Statistical Analysis:  
Assuming a normal distribution of continuous data, the paired T-test will be used to compare 
times to PACU discharge as well as pre- and post-operative spirometry values, ABG 
measurements, and vital signs both between and within groups.  Categorical data (nausea 
yes/no) will be compared using the Chi-square test.