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Nicotine Administration and Post-operative Opioid Use With Bariatric Surgery

NCT01194089 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2015-07-09

Study results available
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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.

Conditions

  • Pain, Postoperative

Interventions

DRUG

Nasal Nicotine Spray

Single 3 mg dose of nasal nicotine spray

DRUG

Nasal Normal Saline Spray

An isotonic solution of sodium chloride 0.65% in deionized water

Sponsors & Collaborators

  • Toby Weingarten

    lead OTHER

Principal Investigators

  • Toby Weingarten, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01194089 on ClinicalTrials.gov