Phase 4
N=350
Deep Neuromuscular Block for Laparoscopic Surgery
Laparoscopy · Anesthesia Recovery Period
Bottom Line
View on ClinicalTrials.gov: NCT03034577 ↗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
| Outcome | Result | p-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
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.