Phase 4 N=89 Randomized Triple-blind Treatment

Nicotine Administration and Post-operative Opioid Use With Bariatric Surgery

Pain, Postoperative

Bottom Line

View on ClinicalTrials.gov: NCT01194089 ↗

Enrolled (actual)

Serious AEs

3.4%

Results posted

Jun 2015

Primary outcome: Primary: Postoperative Opioid Use During the Postanesthesia Care Unit (PACU) Stay, and the First 24 Hours Postoperatively — 5.3; 5.2; 39.6; 32.7 mg — p=0.828

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Nasal Nicotine Spray (Drug); Nasal Normal Saline Spray (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Toby Weingarten
Primary completion: Apr 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Postoperative Opioid Use During the Postanesthesia Care Unit (PACU) Stay, and the First 24 Hours Postoperatively	5.3; 5.2; 39.6; 32.7	0.828
SECONDARY Number of Participants Who Needed to Use Antiemetic Medication in the PACU	24; 12	0.002 sig
SECONDARY Numeric Pain Score	0; 3; 5; 5; 4; 4	0.354

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.

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01194089). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.