The effectiveness of deep versus moderate neuromuscular blockade during laparoscopic donor nephrectomy in enhancing postoperative recovery.

The effectiveness of deep versus moderate neuromuscular blockade during laparoscopic donor nephrectomy in enhancing postoperative recovery. - RELAX-study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42929

Enrollment

Registered

2016-10-27

Start date

2016-11-14

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

kidney donation living donor nephrectomy

Interventions

The patient will be randomized in one of the following study groups: - deep neuromuscular blockade - moderate neuromuscular blockade

Deep neuromuscular blockade

Laparoscopic donornephrectomy

Postoperative recovery

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - individuals scheduled for living kidney donation - age over 18 years - obtained informed consent

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The quality of Recovery score (QoR-40 questionnaire) at 24 hours after extubation	—

Secondary

Measure	Time frame
* 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.	—

Measure

Time frame

* 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.

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Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)