Status:
COMPLETED
Nicotine Administration and Post-operative Opioid Use With Bariatric Surgery
Lead Sponsor:
Toby Weingarten
Conditions:
Pain, Postoperative
Eligibility:
FEMALE
18-60 years
Phase:
PHASE4
Brief Summary
This prospective, randomized, double-blind study will enroll nonsmoking female subjects undergoing laparoscopic bariatric surgery under general anesthesia. The hypothesis of this study is that female ...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT01194089
Start Date
August 1 2010
End Date
April 1 2014
Last Update
July 9 2015
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905