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Deep Neuromuscular Block for Laparoscopic Surgery (DEEPBLOCK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03034577
Recruitment Status : Completed
First Posted : January 27, 2017
Results First Posted : October 21, 2019
Last Update Posted : April 22, 2020
Sponsor:
Collaborators:
Melbourne Health
Peter MacCallum Cancer Centre, Australia
Royal Hospital For Women
Northpark Private Hospital
Information provided by (Responsible Party):
Colin Royse, University of Melbourne

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.

Condition or disease Intervention/treatment Phase
Laparoscopy Anesthesia Recovery Period Drug: Sugammadex Drug: Neostigmine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Trial of Deep Neuromuscular Blockade Reversed With Sugammadex Versus Moderate Neuromuscular Block Reversed With Neostigmine, on Postoperative Quality of Recovery
Actual Study Start Date : June 16, 2017
Actual Primary Completion Date : February 15, 2019
Actual Study Completion Date : April 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

Drug: 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.

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
Drug: 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.




Primary Outcome Measures :
  1. Percentage of Patients Recovered Cognitively at 1 Week [ Time Frame: 1 week ]
    The primary outcome will be the cognitive domain at 1 week after surgery, when it is expected that most of the acute inflammation will have resolved, and analgesia requirements minimal.


Secondary Outcome Measures :
  1. Percentage of Patients Recovered in All Domains of the Postoperative Quality of Recovery Scale at 3 Months After the Operation [ Time Frame: 3 months ]
    Recovery for all domains and within domains of the PostopQRS scale at the other time points of measurement (15 minutes, 40 minutes 1 day, 3 days, 1 and 2 weeks, and 3 months following cessation of anesthesia). The domains of recovery are physiological, nociceptive, emotive activities of daily living, cognitive and overall patient perspective.

  2. Number of Participants With Full Reversal of Neuromuscular Blockade Prior to Extubation [ Time Frame: 6 hours ]
    Compliance with protocol to ensure deep block or light/moderate block, using the train of four ratio and post tetanic count

  3. Duration of Anesthesia From Induction to Cessation of the Anesthetic [ Time Frame: Up to 6 hours ]
    Duration of Anesthesia from induction to cessation of the anesthetic up to 6 hours

  4. Number of Participants Categorized by Level of Surgical Satisfaction [ Time Frame: 2 hours ]
    Overall surgical satisfaction using a 1-5 Likert scale (1 = very unacceptable, 2 = unacceptable, 3 = acceptable, 4 = good, 5 = excellent).

  5. Duration of Hospital Length of Stay [ Time Frame: 3 days ]
    Duration of hospital length of stay following their procedure until hospital discharge



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03034577


Locations
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Australia, Victoria
Northpark Private Hospital
Bundoora, Victoria, Australia, 3083
Melbourne Health
Parkville, Victoria, Australia, 3050
The Royal Womens Hospital
Parkville, Victoria, Australia, 3050
Victorian Comprehensive Cancer Centre
Parkville, Victoria, Australia, 3050
Sponsors and Collaborators
University of Melbourne
Melbourne Health
Peter MacCallum Cancer Centre, Australia
Royal Hospital For Women
Northpark Private Hospital
Investigators
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Principal Investigator: Colin Royse, MD University of Melbourne
  Study Documents (Full-Text)

Documents provided by Colin Royse, University of Melbourne:
Study Protocol  [PDF] November 24, 2016
Statistical Analysis Plan  [PDF] June 17, 2019

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Responsible Party: Colin Royse, Professor of Anesthesia, University of Melbourne
ClinicalTrials.gov Identifier: NCT03034577    
Other Study ID Numbers: 2016.343
First Posted: January 27, 2017    Key Record Dates
Results First Posted: October 21, 2019
Last Update Posted: April 22, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neostigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents