Nicotine Administration and Post-operative Opioid Use With Bariatric Surgery

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: Female

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 nonsmokers who receive nicotine via nasal spray immediately before waking up from anesthesia will need less pain medications 24 hours after the surgery compared to the subjects who receive placebo spray.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Toby Weingarten
• Treatments: Nicotine

Criteria

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.