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Trial record 50 of 185 for:    GLYCOPYRROLATE

Impact of Anesthetic Choice (Sevoflurane Versus Desflurane) on Airway Reflex Recovery in the Context of Antagonized Neuromuscular Block

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ClinicalTrials.gov Identifier: NCT01199237
Recruitment Status : Completed
First Posted : September 10, 2010
Results First Posted : May 8, 2014
Last Update Posted : May 16, 2014
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Airway Reflexes, Protective
Recovery After Neuromuscular Block
Anesthetic Recovery
Interventions Drug: Sevoflurane
Drug: Desflurane
Drug: Rocuronium
Drug: Neostigmine
Drug: Glycopyrrolate
Enrollment 107
Recruitment Details At one U.S. clinical site, patients scheduled to undergo surgery requiring general anesthesia lasting approximately 1.5 - 3.0 hours requiring tracheal intubation and paralysis during surgery were invited to participate
Pre-assignment Details Participation of the first 26 enrollees was considered a pilot to determine the feasibility of measuring the primary outcome at T1+5 minutes. The majority of participants were alert, and no meaningful analyses could be made. The study was modified to assess the primary outcome at T1 + 2 minutes, and 81 additional participants were recruited.
Arm/Group Title Sevoflurane Desflurane
Hide Arm/Group Description Patients received sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg) Patients received Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)
Period Title: Overall Study
Started 41 40
Completed 41 40
Not Completed 0 0
Arm/Group Title Sevoflurane Desflurane Total
Hide Arm/Group Description Patients received sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg) Patients received Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg) Total of all reporting groups
Overall Number of Baseline Participants 41 40 81
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 41 participants 40 participants 81 participants
45.3
(42.0 to 48.7)
43.3
(40.2 to 46.5)
44.3
(40.2 to 48.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 40 participants 81 participants
Female
41
 100.0%
36
  90.0%
77
  95.1%
Male
0
   0.0%
4
  10.0%
4
   4.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 41 participants 40 participants 81 participants
41 40 81
1.Primary Outcome
Title Recovery of Ability to Swallow After Neostigmine/Glycopyrrolate Antagonism of Rocuronium Paralysis.
Hide Description The patient is judged by the primary anesthetist to be awake at time T1. At 2 minutes after T1, the patient was asked to swallow 20mL of water from a paper cup, and a blinded observer judged the ability to swallow based on transit of water to the posterior pharynx (absence of pooling or drooling) and absence of cough or gag.
Time Frame At 2 minutes after response to command (T1).
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants judged by the clinician as able to take the test (n=57)
Arm/Group Title Sevoflurane Desflurane
Hide Arm/Group Description:

Patients receive sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)

Sevoflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water

Patients receive Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)

Desflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water

Overall Number of Participants Analyzed 26 31
Measure Type: Number
Unit of Measure: participants
able to swallow at T1+2 minutes 16 25
unable to swallow at T1+2 minutes 10 6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sevoflurane, Desflurane
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments Significant at p<0.05
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Time From Potent Inhaled Anesthetic Discontinuation to First Response to Command (T1)
Hide Description At the conclusion of surgery, after the patient's potent inhaled anesthetic was discontinued, the commands "open your eyes" and "squeeze my hand" were given at 30-second intervals. The time at which patient first appropriately response to both commands was noted as T1.
Time Frame Up to 1 hour post-operative
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sevoflurane Desflurane
Hide Arm/Group Description:

Patients receive sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)

Sevoflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water

Patients receive Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)

Desflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water

Overall Number of Participants Analyzed 41 40
Mean (Full Range)
Unit of Measure: seconds
623
(509 to 736)
343
(271 to 415)
3.Secondary Outcome
Title Nausea and Vomiting
Hide Description Patients were asked to rate their experience of nausea and vomiting on a 0-10 verbal analog scale, with 0 being absence and 10 being the worst imaginable
Time Frame 30 minutes after T1
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants able to respond at time of assessment
Arm/Group Title Sevoflurane Desflurane
Hide Arm/Group Description:

Patients receive sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)

Sevoflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water

Patients receive Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)

Desflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water

Overall Number of Participants Analyzed 39 39
Mean (Full Range)
Unit of Measure: units on a scale
Nausea
0.385
(0 to 8)
1.359
(0 to 8)
Vomiting
0
(0 to 0)
0
(0 to 0)
4.Secondary Outcome
Title Nausea and Vomiting
Hide Description Patients were asked to rate their experience of nausea and vomiting on a 0-10 verbal analog scale, with 0 being absence and 10 being the worst imaginable
Time Frame 60 minutes after T1
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients able to respond at time of assessment
Arm/Group Title Sevoflurane Desflurane
Hide Arm/Group Description:

Patients receive sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)

Sevoflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water

Patients receive Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)

Desflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water

Overall Number of Participants Analyzed 38 39
Mean (Full Range)
Unit of Measure: units on a scale
Nausea
0.263
(0 to 4)
1.333
(0 to 10)
Vomiting
0
(0 to 0)
0.026
(0 to 1)
5.Secondary Outcome
Title Time From Anesthetic Discontinuation to First Ability to Swallow
Hide Description At 2 minutes after first response to command (T1), the patient was asked to swallow 20 mL of water from a paper cup, and an observer blinded to anesthetic assignment assessed the ability to swallow based on transit of water to the posterior pharynx (absence of pooling or drooling) and absence of cough or gag (indicating misdirection of the water bolus into the laryngeal inlet). This test was repeated at 6, 14, 22, 30 and 60 minutes after the time of first response to command.
Time Frame up to 60 minutes after T1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sevoflurane Desflurane
Hide Arm/Group Description:
Patients received sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)
Patients received Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)
Overall Number of Participants Analyzed 41 40
Mean (Full Range)
Unit of Measure: Seconds
1275
(947 to 1603)
718
(513 to 922)
Time Frame 1-2 hours postoperatively
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sevoflurane Desflurane
Hide Arm/Group Description

Patients receive sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)

Sevoflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water

Patients receive Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)

Desflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water

All-Cause Mortality
Sevoflurane Desflurane
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sevoflurane Desflurane
Affected / at Risk (%) Affected / at Risk (%)
Total   0/41 (0.00%)   0/40 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sevoflurane Desflurane
Affected / at Risk (%) Affected / at Risk (%)
Total   0/41 (0.00%)   0/40 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Rachel Eshima McKay
Organization: University of California, San Francisco
Phone: 415-502-1715
EMail: eshimar@anesthesia.ucsf.edu
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01199237     History of Changes
Other Study ID Numbers: H10722-35629-01
First Submitted: August 23, 2010
First Posted: September 10, 2010
Results First Submitted: April 8, 2014
Results First Posted: May 8, 2014
Last Update Posted: May 16, 2014