Condition category
Surgery
Date applied
15/10/2010
Date assigned
28/04/2011
Last edited
28/04/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Joffrey Klein Ovink

ORCID ID

Contact details

Postbus 5800
Maastricht
6202AZ
Netherlands
j.kleinovink@mumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Does S(+)-ketamine or the combination of S(+)-ketamine and magnesium reduce post-operative opioid requirements after abdominal surgery? A prospective double blinded randomised controlled trial

Acronym

Study hypothesis

The aim of this study was to investigate if the addition of S(+)-ketamine and the addition of the combination of S(+)-ketamine with magnesium sulphate would result in a reduction of opioid requirements compared to a placebo in an existing regimen of post-operative pain treatment with patient controlled analgesia (PCA) with an opioid (piritramide). Secondary aim was the assessment of the effects on post-operative pain scores (Visual Analogue Scale [VAS]) and the incidence of side-effects.

Ethics approval

Medical Ethics Committee Maastricht University Medical Center (MUMC+) approved on the 8th March 2002 (ref: MEC.A.99-107/1)

Study design

Prospective double blinded randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Elective open abdominal surgery

Intervention

Anaesthesia was given in a standardised way; premedication was given using midazolam 3.75 mg orally. Induction using propofol 2 mg/kg, rocuronium 0.6 mg/kg and remifentanyl 0.1 - 1 µg/kg/min by continuous infusion. For maintenance of anaesthesia sevoflurane and remifentanil 0.1 - 1 mg/kg/min were used. No loco-regional blocks were applied.

Study medication was given intravenously (i.v.) as a bolus during induction of the anaesthesia followed by a continuous fixed infusion rate calculated for body weight during 24 hours.

In group C (the control group), patients received a placebo consisting of sodiumchloride (NaCL) 0.9%.

In group K the study medication consisted S(+)-ketamine. A bolus was given of 0.2 mg/kg followed by an infusion at a rate of 2 µg/kg/min.

In group KM the study medication consisted of S(+)-ketamine and magnesium sulphate (MgSO4). A bolus was given of S(+)-ketamine 0.2 mg/kg and MgSO4 of 15 mg/kg followed by an infusion at a rate of 2 µg/kg/min S(+)-ketamine and 5 mg/kg/h MgSO4.

Before the emergence of the anaesthesia every patient received an loading dose piritramide 0.15 mg/kg i.v.. At the PACU all the patients received a patient-controlled-analgesia device (PCA) consisting piritramide without background infusion and a bolus set at 1 mg with a lockout time of 5 minutes.

Intervention type

Drug

Phase

Not Applicable

Drug names

S(+)-ketamine, magnesium

Primary outcome measures

Total amount of piritramide used at 48 hours

Secondary outcome measures

1. Piritramide use at 12 and 24 hours
2. VAS pain scores at 0.5, 1, 2, 3, 4, 8, 12, 24 and 48 hours
3. Vital parameters
4. Incidence of side-effects

Overall trial start date

15/03/2004

Overall trial end date

09/05/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with category I and II American Society of Anesthesiologists (ASA) classification
2. Aged between 18 to 70 years old, either sex

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Extensive previous use of pain therapy
2. Previous strong side-effects caused by ketamine
3. Alcohol abuse
4. Use of psychotropics
5. Severe mental disease
6. Reintervention laparotomy due to complications

Recruitment start date

15/03/2004

Recruitment end date

09/05/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Postbus 5800
Maastricht
6202AZ
Netherlands

Sponsor information

Organisation

Maastricht University Medical Centre (Netherlands)

Sponsor details

Department of Anesthesiology
P.O. Box 5800
Maastrict
6202 AZ
Netherlands
+31 (0)43 387 5606
elvira.marquet@mumc.nl

Sponsor type

Hospital/treatment centre

Website

http://www.azm.nl

Funders

Funder type

Hospital/treatment centre

Funder name

Maastricht University Medical Centre (Netherlands) - Department of Anesthesiology

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes