CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 180 enrolled
Drug / intervention
Bupivacain +6 moredrug
Likely dose
Bupivacain 5 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/NCT00527332
NCT00527332Phase 4Completed

General Anesthesia Versus Spinal Anesthesia Combined With Intrathecal Morphine in Abdominal Hysterectomy for Benign Gynecological Diseases. A Randomized Open Controlled Study.

Preben Kjolhede·interventional·Posted Sep 10, 2007·Updated Jan 26, 2012

In Brief

A Phase 4 clinical trial evaluating Bupivacain, Morphine, and 3 other interventions for Hysterectomy (MeSH nr: E04.950.300.399). Completed, enrolled 180 participants across 5 sites.

Detailed Summary

The purpose of this study is to determine whether spinal anesthesia combined with intrathecal morphine in abdominal hysterectomy on benign gynecological indications gives better outcome concerning duration of hospital stay and postoperative patient comfort than general anesthesia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSweden
Collaborators--

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 10, 2007
Enrollment StartMar 1, 2007
Primary CompletionJun 1, 2009
Study CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 18.8 years ago

Interventions

Bupivacaindrug

5 mg/mL, 4 mL intrathecally as a single dos

Morphinedrug

0.4 mg/mL; 0.5 mL intrathecally as a single dosage

Propofoldrug

2-5 mg/kg body weight/hours IV (intravenously) for sedation during the surgery

Propofoldrug

Induction of anesthesia with 1-2 mg/kg body weight IV (intravenously). After intubation maintenance dosage of 6-10 mg/kg/hour IV during the surgery

Fentanyldrug

100-200 microgram IV (intravenously) at start of anesthesia. 50-100 microgram IV on demand during surgery.

Rocuronbromiddrug

0.6 mg/kg body weight IV (intravenously) at induction of anesthesia. If additional muscle relaxation is needed during surgery 5-10 mg is injected IV. The drug is given only at induction of anesthesia and during surgery

Morphinedrug

5 mg is given IV (intravenously) before end of surgery