Effects of General Anesthesia and Spinal-Morphine Anesthesia on Recovery and Comfort After Benign Abdominal Hysterectomy

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.

Conditions

• Hysterectomy (MeSH nr: E04.950.300.399)

Interventions

DRUG

Bupivacain

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

DRUG

Morphine

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

DRUG

Propofol

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

DRUG

Propofol

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

DRUG

Fentanyl

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

DRUG

Rocuronbromid

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

DRUG

Morphine

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

Sponsors & Collaborators

• Preben Kjolhede

  lead OTHER

Principal Investigators

• Preben Kjölhede, MD, PhD · Department of Obstetrics and Gynecology, University Hospital, Linköping

• Lena Nilsson, MD, PhD · Department of Anesthesiology, University Hospital, Linköping

• Ninnie B. Wodlin, MD · Department of Obstetrics and Gynecology, University Hospital, Linköping

• Kenneth Krohn, MD · Department of Ostetrics and Gynecology, Vrinnevi Hospital, Norrköping

• Lars Nordenberg, MD · Department of Anesthesiology, Vrinnevi Hospital, Norrköping

• Mats D. Karlsson, MD · Department of Obstetrics and Gynecology, Ryhov Hospital, Jönköping

• Veronica Annerhagen, MD · Department of Anesthesiology, Ryhov Hospital, Jönköping

• Christina Gunnervik, MD · Department of Obstetrics and Gynecology, Värnamo Hospital

• Magnus Trofast, MD · Department of Anesthesiology, Värnamo Hospital

• Tomasz Stypa, MD · Department of Obstetrics and Gynecology, Eksjö Hospital

• Albert Sundberg, MD, PhD · Department of Anesthesiology, Eksjö Hospital

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-03-31

Primary Completion

2009-06-30

Completion

2009-12-31

Countries

• Sweden

Study Locations