Does S(+)-ketamine or the combination of S(+)-ketamine and magnesium reduce post-operative opioid requirements after abdominal surgery?
| ISRCTN | ISRCTN17811636 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17811636 |
| Secondary identifying numbers | N/A |
- Submission date
- 15/10/2010
- Registration date
- 28/04/2011
- Last edited
- 28/04/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Joffrey Klein Ovink
Scientific
Scientific
Postbus 5800
Maastricht
6202AZ
Netherlands
| j.kleinovink@mumc.nl |
Study information
| Study design | Prospective double blinded randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | Medical Ethics Committee Maastricht University Medical Center (MUMC+) approved on the 8th March 2002 (ref: MEC.A.99-107/1) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | S(+)-ketamine, magnesium |
| Primary outcome measure | 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 study start date | 15/03/2004 |
| Completion date | 09/05/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 50 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 15/03/2004 |
| Date of final enrolment | 09/05/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Postbus 5800
Maastricht
6202AZ
Netherlands
6202AZ
Netherlands
Sponsor information
Maastricht University Medical Centre (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Anesthesiology
P.O. Box 5800
Maastrict
6202 AZ
Netherlands
| Phone | +31 (0)43 387 5606 |
|---|---|
| elvira.marquet@mumc.nl | |
| Website | http://www.azm.nl |
"ROR" |
https://ror.org/02d9ce178 |
Funders
Funder type
Hospital/treatment centre
Maastricht University Medical Centre (Netherlands) - Department of Anesthesiology
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
