To establish the relationship between the use of deep neuromuscular blockade (NMB) during laparoscopic donor nephrectomy (LDN) -with standard pressure pneumoperitoneum- and the early quality of recovery.
ID
Source
Brief title
Condition
- Renal disorders (excl nephropathies)
- Renal and urinary tract therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The quality of Recovery score (QoR-40 questionnaire) at 24 hours after
extubation
Secondary outcome
* Quality of recovery-40 score at 48 hours after extubation (appendix 1)
Medication use:
* Cumulative opiate use
* Cumulative use of other analgesics and anti-emetics
Intra-operative parameters:
* Surgical conditions; the Surgical Rating Scale is used to quantify the
quality of the surgical field during the pneumoperitoneum phase (after
introduction of the Hasson trocar, after introduction of all trocars and then
every 15 minutes).
* Intra-operative complications (e.g.major bleeding, spleen or liver injury)
* Operation time, length of pneumoperitoneum, first warm ischemia time
* Estimated blood loss
* Conversion to open donor nephrectomy
* Conversion to hand-assisted donor nephrectomy
Clinical parameters:
* Components of pain scores (NRS 0-10):
* Superficial wound pain score at 1, 4, 8 24, 48 hours (after extubation)
* Deep intra-abdominal pain score at 1, 4, 8, 24, 48 hours
* Referred shoulder pain score at 1, 4, 8, 24, 48 hours
* Post-operative nausea and/or vomiting (NRS)
* Time to reach discharge criteria*
Follow up:
* Complications up to 30 days after surgery
* Pain scores 4 weeks afters surgery
* Questionnaire about work and need for medical care
* discharge criteria are: adequate pain control with oral medication, passage
of flatus or defecation, intake of solid food tolerated, patient is mobilized
and independent and patient accepts discharge. Discharge criteria will be
evaluated daily. If the donor for social reasons wants to stay longer (e.g.
long distance from partner of child who are still hospitalized) the *virtual*
discharge date is listed. A physician who is independent and blinded (ward
physician) is responsible for the actual discharge date.
Background summary
Live kidney donation is currently the most effective strategy to manage the
shortage of donor kidneys for transplantation. The increased use of
living donors will decrease the number of patients on the waiting list and this
subsequently reduces mortality of these patients.
Therefore, efforts to optimize safety and postoperative recovery are of great
importance.
Based on the outcomes of previous studies of our group, we hypothesize that the
use of deep NMB during LDN -with standard pressure PNP- enhances early
postoperative recovery as compared to moderate NMB.
Study objective
To establish the relationship between the use of deep neuromuscular blockade
(NMB) during laparoscopic donor nephrectomy (LDN) -with standard pressure
pneumoperitoneum- and the early quality of recovery.
Study design
a multicenter, blinded, randomized controlled trial
Intervention
The patient will be randomized in one of the following study groups:
- deep neuromuscular blockade
- moderate neuromuscular blockade
Study burden and risks
Negligible risk, with a small chance of minimal harm.
The extended effects of deep neuromuscular blockade can lead to post-operative
complications, such as airway obstruction, hypoxia, pneumonia and/or
atelectasis. Therefore, sugammadex, a rapid antagonist of neuromuscular
blockade is given immediately after surgery. Randomized controlled trials have
shown that sugammadex can be safely administered in patients.
Participation is just a small burden for the patients, The questionnaires cost
the patients approximately ten minutes a day.
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
- individuals scheduled for living kidney donation
- age over 18 years
- obtained informed consent
Exclusion criteria
- insufficient control of the Dutch language to read the patient information and to fill out the questionnaires
- chronic use of analgesics or psychotropic drugs
- use of NSAIDs shorter than 5 days before surgery
- known or suspect allergy to rocuronium of sugammadex
- neuromuscular disease
- indication for rapid sequence induction
- deficiency of vitamin K-dependent clotting factors, coagulopathy or use ofcoumarin derivates.
- Peri-operative use of fusidic acid or flucloxacilline
- Severe renal impairment (creatinine clearance <30ml/min)
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 | EUCTR2016-002924-99-NL |
| CCMO | NL58160.091.16 |