Will spinal anaesthesia with sufentanil and bupivacaine heavy cause less hypotension compared to bupivacaine heavy alone? Will there be less use of ephedrine/fenylefrine/noradrenaline if sufentanil is added to bupivacaine heavy for spinal…
ID
Source
Brief title
Condition
- Therapeutic procedures and supportive care NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Haemodynamic change: percentage blood pressure and MAP decrease from baseline
blood pressure in holding and in the operation room. Total amount of
ephedrine/fenylefrine/noradrenaline used to correct blood pressure and MAP.
Secondary outcome
Comparing postoperative pain and side effects between both groups; including
nausea, vomiting, pruritus and dizziness .
Background summary
One of the side effects of intrathecal local anaesthetics is hypotension,
caused by sympathetic blockade. The addition of various doses of opioids may
allow the dose of local anaesthetic to be reduced, producing a synergistic
effect that enhances analgesia, prolongs the duration of the spinal block and
it can be hypothesized that without an increase in degree of sympathetic
blockade it might cause less hypotension compared to administration of a local
anaesthetic alone.
Study objective
Will spinal anaesthesia with sufentanil and bupivacaine heavy cause less
hypotension compared to bupivacaine heavy alone? Will there be less use of
ephedrine/fenylefrine/noradrenaline if sufentanil is added to bupivacaine heavy
for spinal anaesthesia compared to bupivacaine heavy alone?
Study design
Double blind randomized controlled trial
Intervention
Patients in the study group will receive bupivacaine heavy 2 ml (10mg) plus 1
ml sufentanil (5mcg).
Patients in the control group will receive bupivacaine heavy 3 ml (15 mg)
without the addition of sufentanil.
Study burden and risks
Two standard treatments will be compared with each other.
The extra burden for the patients are 7 questions postoperatively in the
recovery room and the patient has to fill in a questionnaire of 7 questions on
the ward
Jan Tooropstraat 164
Amsterdam 1061 AE
NL
Jan Tooropstraat 164
Amsterdam 1061 AE
NL
Listed location countries
Age
Inclusion criteria
Patients undergoing surgery with spinal anaesthesia.
ASA I-III
18-90 years old
Exclusion criteria
- ASA IV-V patients
- Patients younger than 18 years or older than 90 years;Contra-indication for spinal anaesthesia:*
**Severe aortic valve stenosis or severe heart disease
- Local infection at puncture site
- Allergy for local anaesthetics or opioids
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 | EUCTR2015-002843-32-NL |
| CCMO | NL54015.100.15 |