1.To compare the morphine sparing effect of low-dose ketamine in peroperative infusion and in post operative PCA (Morphine use)2.To compare the occurence of side effects.3.To compare the analgesic potential of the two therapies (VAS Scores)4.To…
ID
Source
Brief title
Condition
- Therapeutic and nontherapeutic effects (excl toxicity)
- Therapeutic procedures and supportive care NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. The total morphine use over 72 hours.
2. The occurence of side effects.
3. The VAS scores per study group.
Secondary outcome
1. Evaluation of the levels of the amino-acids (glutamate, glycine, tryptofane,
arginine e.g) and the effect of analgesia on them.
Background summary
The administration of morfine for postoperative analgesia after major surgery
using IV patient-controlled analgetics is a common practice. However it may be
associated with important side-effects such as respiratory depression, nausea
and mvomiting, sedation, hallucinations, urinary retention and prolonged ileus.
The most important side effects are mediated by agonism of the mu-receptor.
A second receptor modulating pain perception present in the central nervous
system is the N-methyl D-aspartate (NMDA) receptor. When NMDA receptors are
stimulated by afferent nociceptive input, they activate a neuronal
sensitization process that enhances pain perception.
Ketamine, an NMDA receptor antagonist, is known to induse dissociate anesthesia.
The combination of morfine and ketamine has been shown to induce an increase in
analgesic effect while a tendency towards a lower incidence of side effects was
observed.
Study objective
1.To compare the morphine sparing effect of low-dose ketamine in peroperative
infusion and in post operative PCA (Morphine use)
2.To compare the occurence of side effects.
3.To compare the analgesic potential of the two therapies (VAS Scores)
4.To evaluate the effect of the therapies on the levels of amino-acids
Study design
A double blind randomized control trial with 2 groups:
Both groups shall receive a standardized post operatieve analgesic treatment
with a Morphine PCA pump.
1. Peroperative bolus administration of saline, post operative 50ml i.v. of
saline over 48 hrs.
2. Peroperative bolus administration of S-Ketamine, post operative 2
microgram/kg/min i.v. of S-Ketamine over 48 hrs.
Study burden and risks
nvt
Dr. Molewaterplein 40
3015 GD Rotterdam
NL
Dr. Molewaterplein 40
3015 GD Rotterdam
NL
Listed location countries
Age
Inclusion criteria
The patient has provided written informed consent prior to admission to the study
The patient is between 18 and 70 years of age
Exclusion criteria
The patient has a history of uncontrolled chronic disease which would contra-indicate study participation.
The patient has severe systemic disease that limits activity and is a constant threat to life (ASA IV).
The patient has a history of chronic substance abuse within the last 3 months.
The patient has a history of psychiatric disorders.
The patient has a history of hypersensitivity to one of the study drugs.
The patient has a history of severe chronic respiratory disorders.
The patient is either breastfeeding or pregnant.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2008-001700-23-NL |
| CCMO | NL22455.078.08 |