CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 95 enrolled
Drug / intervention
Nasal Nicotine Spray +1 moredrug
Likely dose
Nasal Nicotine Spray 3 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01194089
NCT01194089Phase 4Completed
CompareCT.gov

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

Toby Weingarten·interventional·Posted Sep 2, 2010·Updated Jul 9, 2015

In Brief

A Phase 4 clinical trial evaluating Nasal Nicotine Spray and Nasal Normal Saline Spray for Pain, Postoperative. Completed, enrolled 95 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Postoperative
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 2, 2010
Enrollment StartAug 1, 2010
Primary CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 15.8 years ago

Interventions

Nasal Nicotine Spraydrug

Single 3 mg dose of nasal nicotine spray

Nasal Normal Saline Spraydrug

An isotonic solution of sodium chloride 0.65% in deionized water