drugset / Trial / NCT03034577

Deep Neuromuscular Block for Laparoscopic Surgery

NCT03034577

RandomizedParallel-groupSingle-blindTreatment

Summary

Trial summary: deep neuromuscular block is proposed as a technique to improve operative conditions for laparoscopy. Early clinical data would suggest that there may also be patient benefits beyond the operative period related to lower intra-abdominal pressure, and improved surgical exposure. In order to safely conduct deep neuromuscular blockade, it is essential to use Sugammadex to reverse the neuromuscular block. Conventional practice is to provide moderate neuromuscular block and reverse with neostigmine. It is not possible to safely reverse deep neuromuscular block using neostogmine, as the majority of block must have worn off for neostigmine to be effective. in order to identify whether deep neuromuscular block improves quality of recovery after surgery, the investigators will conduct a randomised trial of deep versus moderate neuromuscular block, whilst minimising variance in other anaesthetic techniques and drugs used. the outcome measured will be the post-operative quality of recovery over multiple time periods using the Postoperative Quality of Recovery Scale (PostopQRS). 350 patients will be enrolled over 4 centres.

Timeline

Start
2017-06-16
Primary completion
2019-02-15
Completion
2019-04-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Neostigmine Other / unclassified 50 ug/kg
Comparator Sugammadex Other / unclassified 2 mg/kg
Comparator Sugammadex Other / unclassified 4 mg/kg
Comparator Atropine Other / unclassified 20 ug/kg
Comparator Glycopyrrolate Small molecule 5 ug/kg

Indications

No indication recorded.