- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01194089
Nicotine Administration and Post-operative Opioid Use With Bariatric Surgery
A Randomized, Double Blind, Study to Evaluate the Efficacy of Nasal Nicotine Spray to Reduce Post-Operative Opioid Requirements in Nonsmokers in Elective Laparoscopic Bariatric Surgical Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Though nicotine is known to be a mild analgesic, its use in the peri-operative period to reduce postoperative opioid requirements has only recently been investigated. In nonsmokers it has been shown to reduce postoperative pain and opioid requirements in both female patients undergoing uterine surgery and male patients undergoing prostatectomy. We have recently confirmed these findings in women undergoing uterine surgery by open, laparoscopic and vaginal approaches. In this study we found a 30% mean reduction of 24 hour postoperative opioid requirements following the administration of a 3 mg dose of nicotine nasal spray. Two previous studies with perioperative transdermal nicotine found that increasing doses of nicotine and increasing serum levels of nicotine were associated with higher rates of nausea. In our study, we found that the administration of nasal nicotine was associated with a transient increase of postoperative nausea and vomiting (PONV), but this was limited to the recovery room (PACU) stay. Two studies of nasal nicotine where antiemetics were prophylactically administered did not report the incidence of nausea. In our study, antiemetics were used as rescue medications only. Thus, it is unclear if the prophylactic administration of anti-emetics would effectively counteract the transient emetogenic effect of a small dose of nasal nicotine.
Laparoscopic bariatric surgery is becoming an increasingly popular treatment of morbid obesity. We recently performed a detailed analysis of postoperative pain and opioid requirements among patients that had this type of surgery and found that among non-smokers severe pain (pain > 7/10 on a 10 point scale) was commonly experienced (35%) despite substantial amount of postoperative opioid use (mean 68 mg oral morphine equivalents) and non-opioid analgesics in the first 24 hours. Because obesity related sleep disorders exceed 70% of patients undergoing bariatric surgery, and those disorders are exacerbated by opioids, potential therapies that could reduce postoperative opioid requirements in these patients have substantial value. Further, delayed nausea often poses a problem for these patients meeting hospital discharge criteria, and opioids used for analgesia aggravates this problem. Thus, the use of nasal nicotine could reduce the amount of opioid these patients require for postoperative analgesia. Combined with aggressive antiemetic prophylaxis against PONV, nasal nicotine could paradoxically and indirectly reduce the incidence of nausea in these patients by decreasing postoperative opioid requirements. The proposed study is a randomized clinical trial examining how nicotine affects recovery of female non-smokers undergoing bariatric surgery from general anesthesia. We will test the hypothesis that nicotine, administered in a nasal spray immediately before emergence from anesthesia, will reduce postoperative opioid requirement and postoperative pain. A secondary outcome is to assess if the routine administration of prophylactic antiemetic therapy prevents increased PONV associated with nicotine administration.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) class 2-3
- Non-smokers, defined as not smoking (not even a puff) for at least one year preoperatively, and having smoked less than 100 cigarettes throughout their life or remote history of smoking with complete tobacco abstinence (not even a puff) for at least 10 years
- Scheduled for elective laparoscopic bariatric surgery (other than gastric banding or sleeve resection bariatric surgeries as these are outpatient procedures) requiring general anesthesia.
Exclusion Criteria:
- Regular use of opioid medications in the past year, any prior use of sustained release opioid medications, or history of substance abuse with opioids
- History of previous psychiatric hospitalizations
- Allergy to nicotine
- Previous bariatric surgery or previous foregut surgery
- Pregnant or lactating female (per usual surgical routine)
- Contraindications for receiving ketorolac (elevated creatinine)
- Unstable angina, severe uncontrolled hypertension, serious cardiac dysrhythmias (tachyarrhythmias, atrial fibrillation), or vasospastic diseases (Buerger's disease, Raynaud's phenomena)
- Unable to provide informed consent to participate in the study
- Contraindication to the proposed antiemetics.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Nasal Nicotine Spray
3 mg of nasal nicotine will be administered postoperatively.
|
Single 3 mg dose of nasal nicotine spray
Other Names:
|
Placebo Comparator: Nasal Normal Saline Spray
1 ml of nasal normal saline spray will be administered postoperatively.
|
An isotonic solution of sodium chloride 0.65% in deionized water
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
|
During PACU stay (approximately 94 minutes after operation), 24 hours after operation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Who Needed to Use Antiemetic Medication in the PACU
Time Frame: 24 hours postoperatively.
|
Rescue antiemetic therapy was 0.625 mg droperidol.
Recalcitrant postoperative pain, nausea and vomiting (PONV) was treated per discretion of the supervising anesthesiologist.
|
24 hours postoperatively.
|
Numeric Pain Score
Time Frame: on admission, 30 minutes, 60 minutes, at discharge
|
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).
|
on admission, 30 minutes, 60 minutes, at discharge
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Toby Weingarten, MD, Mayo Clinic
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Ganglionic Stimulants
- Nicotinic Agonists
- Cholinergic Agonists
- Nicotine
Other Study ID Numbers
- 10-002241
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain, Postoperative
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Thoracotomy | Postoperative Pain, Acute | Postoperative Pain, ChronicTurkey
-
Ankara City Hospital BilkentRecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | SternotomyTurkey
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Aydin Adnan Menderes UniversityCompleted
-
Aydin Adnan Menderes UniversityCompletedAcute Postoperative Pain | Chronic Postoperative PainTurkey
-
VA Office of Research and DevelopmentRecruitingTotal Knee Arthroplasty (Postoperative Pain) | Total Hip Arthroplasty (Postoperative Pain)United States
-
VA Office of Research and DevelopmentCompletedTotal Knee Arthroplasty (Postoperative Pain) | Total Hip Arthroplasty(Postoperative Pain)United States
-
Maimonides Medical CenterCompletedPOSTOPERATIVE PAINUnited States
-
University Hospital, AntwerpUnknown
Clinical Trials on Nasal Nicotine Spray
-
University of LausannePharmaciaCompletedSmoking CessationSwitzerland
-
El Instituto Nacional de Neurologia y Neurocirugia...Howard UniversityCompleted
-
VistaGen Therapeutics, Inc.TerminatedSocial Anxiety DisorderUnited States
-
VistaGen Therapeutics, Inc.RecruitingSocial Anxiety DisorderUnited States
-
VistaGen Therapeutics, Inc.CompletedSocial Anxiety DisorderUnited States
-
University of ChicagoMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.Withdrawn
-
Viiral Nordic ABCompleted
-
Imperial College LondonGlaxoSmithKlineCompleted
-
Oyster Point Pharma, Inc.CompletedDry Eye DiseaseUnited States
-
Heinrich-Heine University, DuesseldorfGerman Research FoundationCompletedSchizophrenia | Tobacco Use DisorderGermany