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Phase 4 N=350 Randomized Single-blind Treatment

Deep Neuromuscular Block for Laparoscopic Surgery

Laparoscopy · Anesthesia Recovery Period

Enrolled (actual)
350
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Percentage of Patients Recovered Cognitively at 1 Week — 91.8; 92.9 percentage of patients recovered

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Sugammadex (Drug); Neostigmine (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Melbourne
Primary completion
Feb 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage of Patients Recovered Cognitively at 1 Week
91.8; 92.9
SECONDARY
Percentage of Patients Recovered in All Domains of the Postoperative Quality of Recovery Scale at 3 Months After the Operation
75.7; 73
SECONDARY
Number of Participants With Full Reversal of Neuromuscular Blockade Prior to Extubation
158; 161
SECONDARY
Duration of Anesthesia From Induction to Cessation of the Anesthetic
165.4; 164
SECONDARY
Number of Participants Categorized by Level of Surgical Satisfaction
104; 94; 38; 48; 20; 16
SECONDARY
Duration of Hospital Length of Stay
2.6; 1.8

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.

Eligibility Criteria

Inclusion Criteria

  • Adult participants
  • operative gynecological or abdominal surgery
  • receiving general anesthesia
  • Operation expected to exceed1 hour duration
  • Participants must speak sufficient English to answer the survey questions

Exclusion Criteria

  • Participants undergoing diagnostic laparoscopy only
  • Participants <18 years of age
  • Current pregnancy
  • Known allergy to rocuronium, neostigmine or sugammadex, or desflurane
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03034577). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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