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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03034577




Registration number
NCT03034577
Ethics application status
Date submitted
17/01/2017
Date registered
27/01/2017
Date last updated
22/04/2020

Titles & IDs
Public title
Deep Neuromuscular Block for Laparoscopic Surgery
Scientific title
A Randomized Trial of Deep Neuromuscular Blockade Reversed With Sugammadex Versus Moderate Neuromuscular Block Reversed With Neostigmine, on Postoperative Quality of Recovery
Secondary ID [1] 0 0
2016.343
Universal Trial Number (UTN)
Trial acronym
DEEPBLOCK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Laparoscopy 0 0
Anesthesia Recovery Period 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Sugammadex
Treatment: Drugs - Neostigmine

Active comparator: ModNMB - Moderate Neuromuscular block: participants will receive moderate neuromuscular blockade with rocuronium aiming for TOF 0-2 twitches, with neostigmine reversal when the TOF at least 3 twitches. The depth of neuromuscular block may be reduced after completion of the majority of surgical excision to TOF 3 or more

Neostigmine

Active comparator: DeepNB - Deep Neuromuscular block: participants will receive DNB aiming for a post tetanic count of 1-2, which will be maintained until removal of the laparoscopic ports, with reversal using sugammadex


Treatment: Drugs: Sugammadex
Reversal of neuromuscular block Sugammadex dosage will be adjusted to body weight and PTC/TOF count at the time of reversal, and not administered until PTC at least 1. Dosage will be 4mg/kg if TOF = 0 and PTC = 1; and 2 mg/kg if TOF =1.

Treatment: Drugs: Neostigmine
Neostigmine 50 micrograms/kg coupled with atropine 20 micrograms/kg or glycopyrrolate 5 micrograms/kg, to a maximum dose of neostigmine of 5.0 mg. The neostigmine should not be administered until the TOF has at least 3 twitches present.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Patients Recovered Cognitively at 1 Week
Timepoint [1] 0 0
1 week
Secondary outcome [1] 0 0
Percentage of Patients Recovered in All Domains of the Postoperative Quality of Recovery Scale at 3 Months After the Operation
Timepoint [1] 0 0
3 months
Secondary outcome [2] 0 0
Number of Participants With Full Reversal of Neuromuscular Blockade Prior to Extubation
Timepoint [2] 0 0
6 hours
Secondary outcome [3] 0 0
Duration of Anesthesia From Induction to Cessation of the Anesthetic
Timepoint [3] 0 0
Up to 6 hours
Secondary outcome [4] 0 0
Number of Participants Categorized by Level of Surgical Satisfaction
Timepoint [4] 0 0
2 hours
Secondary outcome [5] 0 0
Duration of Hospital Length of Stay
Timepoint [5] 0 0
3 days

Eligibility
Key inclusion criteria
1. Adult participants
2. operative gynecological or abdominal surgery
3. receiving general anesthesia
4. Operation expected to exceed1 hour duration
5. Participants must speak sufficient English to answer the survey questions
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participants undergoing diagnostic laparoscopy only
2. Participants <18 years of age
3. Current pregnancy
4. Known allergy to rocuronium, neostigmine or sugammadex, or desflurane

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/06/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2019
Sample size
Target
Accrual to date
Final
350
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Northpark Private Hospital - Bundoora
Recruitment hospital [2] 0 0
Melbourne Health - Parkville
Recruitment hospital [3] 0 0
The Royal Womens Hospital - Parkville
Recruitment hospital [4] 0 0
Victorian Comprehensive Cancer Centre - Parkville
Recruitment postcode(s) [1] 0 0
3083 - Bundoora
Recruitment postcode(s) [2] 0 0
3050 - Parkville

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Melbourne Health
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Peter MacCallum Cancer Centre, Australia
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Royal Hospital For Women
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Northpark Private Hospital
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT03034577
Trial related presentations / publications
Boggett S, Chahal R, Griffiths J, Lin J, Wang D, Williams Z, Riedel B, Bowyer A, Royse A, Royse C. A randomised controlled trial comparing deep neuromuscular blockade reversed with sugammadex with moderate neuromuscular block reversed with neostigmine. Anaesthesia. 2020 Sep;75(9):1153-1163. doi: 10.1111/anae.15094. Epub 2020 May 12.
Public notes

Contacts
Principal investigator
Name 0 0
Colin Royse, MD
Address 0 0
University of Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03034577