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Nicotine Administration and Post-operative Opioid Use With Bariatric Surgery

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ClinicalTrials.gov Identifier: NCT01194089
Recruitment Status : Completed
First Posted : September 2, 2010
Results First Posted : June 3, 2015
Last Update Posted : July 9, 2015
Sponsor:
Information provided by (Responsible Party):
Toby Weingarten, Mayo Clinic

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Pain, Postoperative
Interventions: Drug: Nasal Nicotine Spray
Drug: Nasal Normal Saline Spray

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were enrolled at Mayo Clinic in Rochester, Minnesota from August 2010 to March 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
95 subjects randomized; 48 to Placebo arm, and 47 to Nicotine arm. On the Placebo arm one subject had their surgery rescheduled and did not take part in the study, leaving 47 starting. On the Nicotine arm 3 subjects withdrew consent prior to surgery and 1 subject's surgery was cancelled, and 1 subject surgery rescheduled, leaving 42 starting.

Reporting Groups
  Description
Nasal Nicotine Spray 3 mg of nasal nicotine will be administered postoperatively.
Nasal Normal Saline Spray 1 ml of nasal normal saline spray will be administered postoperatively.

Participant Flow:   Overall Study
    Nasal Nicotine Spray   Nasal Normal Saline Spray
STARTED   42   47 
COMPLETED   42   47 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Nasal Nicotine Spray 3 mg of nasal nicotine will be administered postoperatively.
Nasal Normal Saline Spray 1 ml of nasal normal saline spray will be administered postoperatively.
Total Total of all reporting groups

Baseline Measures
   Nasal Nicotine Spray   Nasal Normal Saline Spray   Total 
Overall Participants Analyzed 
[Units: Participants]
 42   47   89 
Age 
[Units: Years]
Mean (Standard Deviation)
 46.0  (9.1)   44.9  (10.6)   45.8  (9.9) 
Gender 
[Units: Participants]
     
Female   42   47   89 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   42   47   89 


  Outcome Measures

1.  Primary:   Postoperative Opioid Use During the Postanesthesia Care Unit (PACU) Stay, and the First 24 Hours Postoperatively   [ Time Frame: During PACU stay (approximately 94 minutes after operation), 24 hours after operation ]

2.  Secondary:   Number of Participants Who Needed to Use Antiemetic Medication in the PACU   [ Time Frame: 24 hours postoperatively. ]

3.  Secondary:   Numeric Pain Score   [ Time Frame: on admission, 30 minutes, 60 minutes, at discharge ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Toby N. Weingarten
Organization: Mayo Clinic
phone: 507-255-1612
e-mail: weingarten.toby@mayo.edu


Publications of Results:

Responsible Party: Toby Weingarten, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01194089     History of Changes
Other Study ID Numbers: 10-002241
First Submitted: September 1, 2010
First Posted: September 2, 2010
Results First Submitted: May 13, 2015
Results First Posted: June 3, 2015
Last Update Posted: July 9, 2015