A randomized controlled trial comparing deep versus moderate neuromuscular block - in low pressure pneumoperitoneum - to optimize the surgical conditions during laparoscopic donor nephrectomy

A randomized controlled trial comparing deep versus moderate neuromuscular block - in low pressure pneumoperitoneum - to optimize the surgical conditions during laparoscopic donor nephrectomy - LEOPARD-3 study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40989

Enrollment

Registered

2014-11-10

Start date

2014-08-26

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

donor nephrectomy kidney donation

Interventions

The patient will be randomized in one the following study groups: • Low pressure pneumoperitoneum (6 mmHg) and deep neuromuscular blockade (goal: TOF 0-1 twitches) • Low pressure pneumoperitoneum (6

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: obtained informed consent age >18 years

Exclusion criteria

Exclusion criteria: • chronic use of analgetics or psychotropic drugs • use of NSAIDs shorter than 5 days before surgery • known of suspect allergy to rocuronium or sugammadex • significant liver* or renal** dysfunction • pregnant of breastfeeding;* Liver dysfunction is defined as alanine aminotransferase (ALAT) and/or aspartate aminotransferase (ASAT) > twice the upper limit (extremely rare in live kidney donors) ** Renal dysfunction is defined as serum creatinine twice the normal level and/or glomerular filtration rate

Design outcomes

Primary

Measure	Time frame
Mean surgical rating score	—

Secondary

Measure	Time frame
Questionnaires • Quality of recovery-40 questionnaire Medication use • Cumulative use of analgetics • Cumulative use of anti-emetics Intra-operative parameters • Operation time (min), length of pneuoperitoneum (min), first warm ischemia time (sec) • Estimated blood loss (ml) • Conversion to open donor nephrectomy (incidence) • Conversion to hand-assisted donor nephrectomy (incidence) • Intra-operative complications (e.g. bleeding, injury to spleen or liver) • Cumulative use of rocuronium (mg) • Cumulative use of sugammadex (mg) • Intra-abdominal volume (mL) Clinical parameters • Components of pain assessment • Evaluation of post-operative complications, graded according to Clavien Dindo • Post-operative incidence of nausea and/or vomiting • Serum creatinine	—

Measure

Time frame

Questionnaires • Quality of recovery-40 questionnaire Medication use • Cumulative use of analgetics • Cumulative use of anti-emetics Intra-operative parameters • Operation time (min), length of pneuoperitoneum (min), first warm ischemia time (sec) • Estimated blood loss (ml) • Conversion to open donor nephrectomy (incidence) • Conversion to hand-assisted donor nephrectomy (incidence) • Intra-operative complications (e.g. bleeding, injury to spleen or liver) • Cumulative use of rocuronium (mg) • Cumulative use of sugammadex (mg) • Intra-abdominal volume (mL) Clinical parameters • Components of pain assessment • Evaluation of post-operative complications, graded according to Clavien Dindo • Post-operative incidence of nausea and/or vomiting • Serum creatinine

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)