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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
Enrollment 95

Recruitment Details Subjects were enrolled at Mayo Clinic in Rochester, Minnesota from August 2010 to March 2014.
Pre-assignment Details 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.
Arm/Group Title Nasal Nicotine Spray Nasal Normal Saline Spray
Hide Arm/Group Description 3 mg of nasal nicotine will be administered postoperatively. 1 ml of nasal normal saline spray will be administered postoperatively.
Period Title: Overall Study
Started 42 47
Completed 42 47
Not Completed 0 0
Arm/Group Title Nasal Nicotine Spray Nasal Normal Saline Spray Total
Hide Arm/Group Description 3 mg of nasal nicotine will be administered postoperatively. 1 ml of nasal normal saline spray will be administered postoperatively. Total of all reporting groups
Overall Number of Baseline Participants 42 47 89
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants 47 participants 89 participants
46.0  (9.1) 44.9  (10.6) 45.8  (9.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 47 participants 89 participants
Female
42
 100.0%
47
 100.0%
89
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 42 participants 47 participants 89 participants
42 47 89
1.Primary Outcome
Title Postoperative Opioid Use During the Postanesthesia Care Unit (PACU) Stay, and the First 24 Hours Postoperatively
Hide Description Opioid use was calculated in intravenous morphine equivalents (iv MEQ) according to the Mayo Clinic Pharmacy opioid conversion calculator based on the recommendations from the American Pain Society. Specifically, the following conversion was used: 10 mg in MEQ=100mcg iv fentanyl=1.5 mg iv hydromorphone=20mg oral oxycodone=30mg oral hydrocodone.
Time Frame During PACU stay (approximately 94 minutes after operation), 24 hours after operation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nasal Nicotine Spray Nasal Normal Saline Spray
Hide Arm/Group Description:
3 mg of nasal nicotine will be administered postoperatively.
1 ml of nasal normal saline spray will be administered postoperatively.
Overall Number of Participants Analyzed 42 47
Median (Inter-Quartile Range)
Unit of Measure: mg
During the PACU stay
5.3
(0 to 10.0)
5.2
(0 to 12.7)
First 24 hours postoperatively
39.6
(20.0 to 52.5)
32.7
(20.3 to 51.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nasal Nicotine Spray, Nasal Normal Saline Spray
Comments Comparison between arms for the postoperative opioid use during the postanesthesia care unit (PACU) stay, using a one tailed P value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.828
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Nasal Nicotine Spray, Nasal Normal Saline Spray
Comments Comparison between the arms for the first 24 hours postoperatively, using a one tailed P value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.752
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants Who Needed to Use Antiemetic Medication in the PACU
Hide Description Rescue antiemetic therapy was 0.625 mg droperidol. Recalcitrant postoperative pain, nausea and vomiting (PONV) was treated per discretion of the supervising anesthesiologist.
Time Frame 24 hours postoperatively.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nasal Nicotine Spray Nasal Normal Saline Spray
Hide Arm/Group Description:
3 mg of nasal nicotine will be administered postoperatively.
1 ml of nasal normal saline spray will be administered postoperatively.
Overall Number of Participants Analyzed 42 47
Measure Type: Number
Unit of Measure: participants
24 12
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nasal Nicotine Spray, Nasal Normal Saline Spray
Comments Comparison between the arms for antiemetic medication use in the PACU.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
3.Secondary Outcome
Title Numeric Pain Score
Hide Description Upon arrival in the PACU and at least every 30 minutes thereafter while in the PACU, the subject was asked to report pain using a numerical pain score for current pain at rest from 0 (representing no pain) to 10 (representing the worst imaginable pain).
Time Frame on admission, 30 minutes, 60 minutes, at discharge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not all participants completed the pain scale at every time point. The participants analyzed per arm (nicotine, normal) at each time point were: on admission (40, 45); 30 minutes (40, 47); 60 minutes (34, 40); at discharge (39, 44),
Arm/Group Title Nasal Nicotine Spray Nasal Normal Saline Spray
Hide Arm/Group Description:
3 mg of nasal nicotine will be administered postoperatively.
1 ml of nasal normal saline spray will be administered postoperatively.
Overall Number of Participants Analyzed 40 47
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
On admission
0
(0 to 6)
3
(0 to 6)
30 minutes
5
(0.5 to 6)
5
(0 to 7)
60 minutes
4
(2 to 6)
4
(3 to 5)
At discharge
3
(2 to 4)
3
(2 to 4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nasal Nicotine Spray, Nasal Normal Saline Spray
Comments The arms were compared for numeric pain score on admission.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.354
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Nasal Nicotine Spray, Nasal Normal Saline Spray
Comments The arms were compared for numeric pain score at 30 minutes.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.492
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Nasal Nicotine Spray, Nasal Normal Saline Spray
Comments The arms were compared for numeric pain score at 60 minutes.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.809
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Nasal Nicotine Spray, Nasal Normal Saline Spray
Comments The arms were compared for numeric pain score at discharge.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.381
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nasal Nicotine Spray Nasal Normal Saline Spray
Hide Arm/Group Description 3 mg of nasal nicotine will be administered postoperatively. 1 ml of nasal normal saline spray will be administered postoperatively.
All-Cause Mortality
Nasal Nicotine Spray Nasal Normal Saline Spray
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Nasal Nicotine Spray Nasal Normal Saline Spray
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/42 (4.76%)      1/47 (2.13%)    
Blood and lymphatic system disorders     
Blood transfusion   1/42 (2.38%)  1 0/47 (0.00%)  0
Gastrointestinal disorders     
Readmission for postoperative pain, nausea, and vomiting   0/42 (0.00%)  0 1/47 (2.13%)  1
Surgical and medical procedures     
Anastomotic leak  [1]  1/42 (2.38%)  1 0/47 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
An anastomotic leak is a breakdown along an anastomosis which causes fluids to leak. Anastomoses are used when a hollow organ needs to be severed and reconnected to allow fluids to flow through it.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Nasal Nicotine Spray Nasal Normal Saline Spray
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   28/42 (66.67%)      24/47 (51.06%)    
Gastrointestinal disorders     
Postoperative pain, nausea, and vomiting (PONV)  [1]  27/42 (64.29%)  27 24/47 (51.06%)  24
Respiratory, thoracic and mediastinal disorders     
Nasal burning  [2]  1/42 (2.38%)  1 0/47 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
PONV was defined as any nausea score >0, use of rescue medication, or visible retching or vomiting.
[2]
At the end of 24 hours after the operation subjects were queried for the presence of nasal burning.
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
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