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Effect of Intraoperative Anesthetic Management on Postoperative Nausea and Vomiting in Bariatric Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01449708
Recruitment Status : Completed
First Posted : October 10, 2011
Results First Posted : March 21, 2016
Last Update Posted : March 21, 2016
Sponsor:
Information provided by (Responsible Party):
Patrick Ziemann-Gimmel, Coastal Anesthesiology Consultants

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Condition Postoperative Nausea and Vomiting
Intervention Drug: TIVA NoNarc
Enrollment 124
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Classic/Balanced Anesthesia TIVA
Hide Arm/Group Description

Patients will receive balanced general anesthesia including volatile anesthetics and narcotics. This reflects our current clinical practice. (Control)

postop management in both groups is similar in both groups

TIVA NoNarc (Study): - patients in both groups receive antiemetic prophylaxis

- patients in the TIVA NoNarc group will receive propofol, dexmedetomidine, ketamine, ketorolac and acetaminophen intraoperatively

Period Title: Overall Study
Started 61 63
Completed 59 60
Not Completed 2 3
Reason Not Completed
Protocol Violation             0             1
surgical complication             1             2
respiratory failure             1             0
Arm/Group Title Classic/Balanced Anesthesia TIVA Total
Hide Arm/Group Description

Patients will receive balanced general anesthesia including volatile anesthetics and narcotics. This reflects our current clinical practice.

  • patients in both groups receive antiemetic prophylaxis
  • postop management in both groups is similar in both groups
  • patients in both groups receive antiemetic prophylaxis
  • patients in the TIVA NoNarc group will receive propofol, dexmedetomidine, ketamine, ketorolac and acetaminophen intraoperatively
  • postop management in both groups is similar in both groups
Total of all reporting groups
Overall Number of Baseline Participants 59 60 119
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 59 participants 60 participants 119 participants
50.4  (3.2) 50.5  (3.5) 50.4  (2.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 60 participants 119 participants
Female
43
  72.9%
39
  65.0%
82
  68.9%
Male
16
  27.1%
21
  35.0%
37
  31.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 59 participants 60 participants 119 participants
59 60 119
1.Primary Outcome
Title PONV During the First 24 Hours After Bariatric Surgery
Hide Description Postoperative Nausea and Vomiting
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Classic / Balanced Anesthesia TIVA
Hide Arm/Group Description:
Patients will receive balanced general anesthesia including volatile anesthetics and narcotics. (Control)
patients in the TIVA NoNarc group will receive propofol, dexmedetomidine, ketamine, ketorolac and acetaminophen intraoperatively
Overall Number of Participants Analyzed 59 60
Measure Type: Number
Unit of Measure: participants
22 12
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Classic / Balanced Anesthesia, TIVA
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Relative Risk
Estimated Value 1.27
Confidence Interval (2-Sided) 95%
1.01 to 1.61
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Patients Requiring Antiemetic Rescue Medication (AERM)
Hide Description [Not Specified]
Time Frame 24hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Classic/Balanced Anesthesia TIVA
Hide Arm/Group Description:

Patients will receive balanced general anesthesia including volatile anesthetics and narcotics. This reflects our current clinical practice. (Control)

postop management in both groups is similar in both groups

TIVA NoNarc (Study): - patients in both groups receive antiemetic prophylaxis

- patients in the TIVA NoNarc group will receive propofol, dexmedetomidine, ketamine, ketorolac and acetaminophen intraoperatively

Overall Number of Participants Analyzed 59 60
Measure Type: Number
Unit of Measure: participants
26 17
3.Secondary Outcome
Title PONV Between Different Surgical Procedures (Percentage of Participants)
Hide Description [Not Specified]
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
analysis was conducted with all participants and NOT per arm
Arm/Group Title All Study Participants
Hide Arm/Group Description:
measure included all119 patients depending on surgical procedure
Overall Number of Participants Analyzed 119
Measure Type: Number
Unit of Measure: percentage of participants
Sleeve Gastrectomy 58.6
Gastric Bypass (LRYGB) 19.4
Gastric Band 0
revision LRYGB 23.1
Conversion to LRYGB 0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Study Participants
Comments Grouping of surgical procedures into three categories, analysis using bonferroni correction, 1) ReY group( gastric bypass, conversion to gastric bypass and revision gastric bypass) 2) Gastric Band (GB), 3) sleeve gastrectomy (SG)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.04
Confidence Interval (2-Sided) 95%
1.28 to 7.29
Estimation Comments [Not Specified]
Time Frame 24hours
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Classic/Balanced Anesthesia TIVA
Hide Arm/Group Description Patients will receive balanced general anesthesia including volatile anesthetics and narcotics. (Control) patients in the TIVA NoNarc group will receive propofol, dexmedetomidine, ketamine, ketorolac and acetaminophen intraoperatively
All-Cause Mortality
Classic/Balanced Anesthesia TIVA
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Classic/Balanced Anesthesia TIVA
Affected / at Risk (%) Affected / at Risk (%)
Total   0/59 (0.00%)   0/60 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Classic/Balanced Anesthesia TIVA
Affected / at Risk (%) Affected / at Risk (%)
Total   0/59 (0.00%)   0/60 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Patrick Ziemann-Gimmel, MD
Organization: Coastal Anesthesiology
Phone: 904-819-4478
EMail: pziemann@yahoo.com
Layout table for additonal information
Responsible Party: Patrick Ziemann-Gimmel, Coastal Anesthesiology Consultants
ClinicalTrials.gov Identifier: NCT01449708    
Other Study ID Numbers: 3766 - 6886
First Submitted: October 6, 2011
First Posted: October 10, 2011
Results First Submitted: February 27, 2015
Results First Posted: March 21, 2016
Last Update Posted: March 21, 2016