CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 23 enrolled
Drug / intervention
Nicotine (drug)drug
Likely dose
Nicotine nasal spray 3 mg administered before surgeryAI-extracted
Key inclusion· 3
  • Age 18 years or older
  • Female sex
  • Presenting for open pelvic surgery at New York Presbyterian Hospital
Key exclusion· 4
  • Current or former smoking history
  • Uncontrolled hypertension
  • Myocardial disease
  • History of stroke

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

Search/NCT00232817
NCT00232817Phase 4Completed

Intranasal Nicotine for Postoperative Pain Treatment: A Comparison of Its Effects in the Context of Isoflurane-induced Anesthesia Versus Propofol Anesthesia

Columbia University·interventional·Posted Oct 5, 2005·Updated Jul 12, 2024

In Brief

A Phase 4 clinical trial evaluating Nicotine (drug) for Postoperative Pain. Completed, enrolled 23 participants across 1 site.

Detailed Summary

The purpose of this study is to compare post-operative pain after anesthesia with either isoflurane or propofol. Each group will be further randomized to receive intranasal nicotine or placebo in order to detect potential pronociceptive action of isoflurane. The study is a randomized, prospective, double-blinded controlled trial. Eighty adult women undergoing uterine surgery will be recruited for this study. Enrollment in this study is limited to women, because the animal studies suggest that females have a greater hyperalgesic response to volatile anesthetics than do males. The patient will be given one of two standard anesthetics for their surgery: isoflurane or propofol. The investigators are interested in these two anesthetics because we seek to see if there exists a difference in their effects on a patient's perception of pain, as has been shown to be the case in animal studies but has not yet been studied in humans.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 5, 2005
Enrollment StartJul 1, 2003
Primary CompletionJul 1, 2005
Study CompletionMar 1, 2006
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 20.7 years ago

Interventions

Nicotine (drug)drug

nicotine nasal spray (3mg) before surgery