Deep Versus Moderate Muscle Relaxation During Laparoscopi... | NCT02838134

NCT02838134

Status Module

Sponsor/Collaborators Module

Name	Class
Merck Sharp & Dohme LLC	INDUSTRY

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A: Deep Neuromuscular blockade	Experimental	An extra bolus of rocuronium after intubation followed by infusion	Other: Rocuronium
Group B: Moderate neuromuscular Blockade	Sham Comparator	Moderate neuromuscular Blockade No additional rocuronium after intubation.	Other: No additional Rocuronium

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rocuronium	Other	A bolus of 0.7 mg/kg rocuronium is administered just after tracheal intubation and then an infusion of rocuronium (0.3 to 0.4 mg/kg) is started when post-tetanic count (PTC) is more than 0 and titrated towards PTC 1-2.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total Score of the Quality of Recovery-40 Questionnaire (QoR-40)	The QoR-40 is a validated assessment tool for measuring a patient's self-assessed quality of recovery after surgery. It consists of 40 questions measuring 5 dimensions: patient support, comfort, emotions, physical independence and pain. Each item is rated on a scale of 1 to 5, giving a minimal score of 40 and a maximum score of 200. Higher values represent a better outcome	Day 1: 24 hours after detubation

Secondary Outcomes

Measure	Description	Time Frame
Surgical Conditions	Surgical rating score, concerning the quality of the surgical field, scored with the surgical rating scale (SRS) A likert scale from 1 to 5. Higher scores represent better outcomes. = extremely poor conditions = poor conditions = acceptable conditions =good conditions = optimal conditions	Day 0: Intraoperative, average of scores up to 240 minutes (assessed each 15 minutes)

Eligibility Module

Contacts/Locations Module

Overall Officials

Name	Affiliation	Role
Moira Bruintjes, Msc.	Radboud University Medical Center	Principal Investigator
Michiel Warlé, Dr.	Radboud University Medical Center	Principal Investigator
Andries E Braat, Dr.	LUMC	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34879862	Derived	Reijnders-Boerboom GTJA, van Helden EV, Minnee RC, Albers KI, Bruintjes MHD, Dahan A, Martini CH, d'Ancona FCH, Scheffer GJ, Keijzer C, Warle MC. Deep neuromuscular block reduces the incidence of intra-operative complications during laparoscopic donor nephrectomy: a pooled analysis of randomized controlled trials. Perioper Med (Lond). 2021 Dec 9;10(1):56. doi: 10.1186/s13741-021-00224-1.
32107359

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Group A: Deep Neuromuscular Blockade	An extra bolus of rocuronium after intubation followed by infusion Rocuronium: A bolus of 0.7 mg/kg rocuronium is administered just after tracheal intubation and then an infusion of rocuronium (0.3 to 0.4 mg/kg) is started when post-tetanic count (PTC) is more than 0 and titrated towards PTC 1-2.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Aug 23, 2016

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Masking Info

Group A: Deep Neuromuscular blockade

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Group A: Deep Neuromuscular Blockade	An extra bolus of rocuronium after intubation followed by infusion Rocuronium: A bolus of 0.7 mg/kg rocuronium is administered just after tracheal intubation and then an infusion of rocuronium (0.3 to 0.4 mg/kg) is started when PTC is more than 0 and titrated towards PTC 1-2.
BG001	Group B: Moderate Neuromuscular Blockade	Moderate neuromuscular Blockade No additional rocuronium after intubation. No additional Rocuronium: No additional rocuronium is administered after tracheal intubation.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00048 BG00148 BG00296

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG000169.3± 18.3 OG001169.5± 15.5

Secondary

Surgical Conditions

Surgical rating score, concerning the quality of the surgical field, scored with the surgical rating scale (SRS) A likert scale from 1 to 5. Higher scores represent better outcomes.

= extremely poor conditions
= poor conditions
= acceptable conditions
=good conditions
= optimal conditions

Posted

Mean

Standard Deviation

score on a scale

Day 0: Intraoperative, average of scores up to 240 minutes (assessed each 15 minutes)

ID	Title	Description
OG000	Group A: Deep Neuromuscular Blockade	An extra bolus of rocuronium after intubation followed by infusion Rocuronium: A bolus of 0.7 mg/kg rocuronium is administered just after tracheal intubation and then an infusion of rocuronium (0.3 to 0.4 mg/kg) is started when PTC is more than 0 and titrated towards PTC 1-2.
OG001	Group B: Moderate Neuromuscular Blockade	Moderate neuromuscular Blockade No additional rocuronium after intubation. No additional Rocuronium: No additional rocuronium is administered after tracheal intubation.

Units	Counts
Participants

Secondary

Length of Pneumoperitoneum

Intraoperative parameter of duration of pneumoperitoneum

Posted

Mean

Standard Deviation

minutes

Day 0: once, up to 240 minutes

ID	Title	Description
OG000	Group A: Deep Neuromuscular Blockade	An extra bolus of rocuronium after intubation followed by infusion Rocuronium: A bolus of 0.7 mg/kg rocuronium is administered just after tracheal intubation and then an infusion of rocuronium (0.3 to 0.4 mg/kg) is started when PTC is more than 0 and titrated towards PTC 1-2.
OG001	Group B: Moderate Neuromuscular Blockade	Moderate neuromuscular Blockade No additional rocuronium after intubation. No additional Rocuronium: No additional rocuronium is administered after tracheal intubation.

Units	Counts
Participants	OG000

Secondary

Warm Ischemia Time

Intraoperative parameter measuring the time (in minutes) between dissection of the renal artery and flushing of the kidney after retrieval

Posted

Mean

Standard Deviation

minutes

Day 0: once, up to 240 minutes

ID	Title	Description
OG000	Group A: Deep Neuromuscular Blockade	An extra bolus of rocuronium after intubation followed by infusion Rocuronium: A bolus of 0.7 mg/kg rocuronium is administered just after tracheal intubation and then an infusion of rocuronium (0.3 to 0.4 mg/kg) is started when PTC is more than 0 and titrated towards PTC 1-2.
OG001	Group B: Moderate Neuromuscular Blockade	Moderate neuromuscular Blockade No additional rocuronium after intubation. No additional Rocuronium: No additional rocuronium is administered after tracheal intubation.

Units	Counts
Participants	OG000

Secondary

Estimated Blood Loss

Intraoperative parameter

Posted

Mean

Standard Deviation

Day 0: once, up to 240 minutes

ID	Title	Description
OG000	Group A: Deep Neuromuscular Blockade	An extra bolus of rocuronium after intubation followed by infusion Rocuronium: A bolus of 0.7 mg/kg rocuronium is administered just after tracheal intubation and then an infusion of rocuronium (0.3 to 0.4 mg/kg) is started when PTC is more than 0 and titrated towards PTC 1-2.
OG001	Group B: Moderate Neuromuscular Blockade	Moderate neuromuscular Blockade No additional rocuronium after intubation. No additional Rocuronium: No additional rocuronium is administered after tracheal intubation.

Units	Counts
Participants	OG000

Secondary

Conversion

Number of Participants with conversion to open or hand-assisted donor nephrectomy

Posted

Count of Participants

Participants

Day 0: once, up to 240 minutes

ID	Title	Description
OG000	Group A: Deep Neuromuscular Blockade	An extra bolus of rocuronium after intubation followed by infusion Rocuronium: A bolus of 0.7 mg/kg rocuronium is administered just after tracheal intubation and then an infusion of rocuronium (0.3 to 0.4 mg/kg) is started when PTC is more than 0 and titrated towards PTC 1-2.
OG001	Group B: Moderate Neuromuscular Blockade	Moderate neuromuscular Blockade No additional rocuronium after intubation. No additional Rocuronium: No additional rocuronium is administered after tracheal intubation.

Units	Counts
Participants	OG000

Secondary

Intra-operative Complications

Number of Participants with Complications which occurred during surgery

Posted

Count of Participants

Participants

Day 0: once, up to 240 minutes

ID	Title	Description
OG000	Group A: Deep Neuromuscular Blockade	An extra bolus of rocuronium after intubation followed by infusion Rocuronium: A bolus of 0.7 mg/kg rocuronium is administered just after tracheal intubation and then an infusion of rocuronium (0.3 to 0.4 mg/kg) is started when PTC is more than 0 and titrated towards PTC 1-2.
OG001	Group B: Moderate Neuromuscular Blockade	Moderate neuromuscular Blockade No additional rocuronium after intubation. No additional Rocuronium: No additional rocuronium is administered after tracheal intubation.

Units	Counts
Participants	OG000

Secondary

Cumulative Use of Rocuronium

Total amount of rocuronium administered during surgery

Posted

Mean

Standard Deviation

Day 0: once, up to 240 minutes

ID	Title	Description
OG000	Group A: Deep Neuromuscular Blockade	An extra bolus of rocuronium after intubation followed by infusion Rocuronium: A bolus of 0.7 mg/kg rocuronium is administered just after tracheal intubation and then an infusion of rocuronium (0.3 to 0.4 mg/kg) is started when PTC is more than 0 and titrated towards PTC 1-2.
OG001	Group B: Moderate Neuromuscular Blockade	Moderate neuromuscular Blockade No additional rocuronium after intubation. No additional Rocuronium: No additional rocuronium is administered after tracheal intubation.

Units	Counts
Participants	OG000

Secondary

Total Score of the Quality of Recovery-40 Questionnaire

Posted

Mean

Standard Deviation

score on a scale

Day 2: 48 hours after detubation

ID	Title	Description
OG000	Group A: Deep Neuromuscular Blockade	An extra bolus of rocuronium after intubation followed by infusion Rocuronium: A bolus of 0.7 mg/kg rocuronium is administered just after tracheal intubation and then an infusion of rocuronium (0.3 to 0.4 mg/kg) is started when PTC is more than 0 and titrated towards PTC 1-2.
OG001	Group B: Moderate Neuromuscular Blockade	Moderate neuromuscular Blockade No additional rocuronium after intubation. No additional Rocuronium: No additional rocuronium is administered after tracheal intubation.

Units	Counts
Participants

Secondary

Postoperative Pain

components of pain scores after 1 hour, 6 hours, on postoperative day 1 (POD1) and postoperative day 2 (POD2).

Likert scale from 0 to 10. Higher scores represent more pain.

1 patient from the moderate NMB group was not able to complete the questionnaires on day 1 and day 2 because of personal circumstances.

Posted

Mean

Standard Deviation

score on a scale

Day 0: 1h, 6h, day 1: 24h and day 2: 48 hours (and if still admitted 72h) after detubation

ID	Title	Description
OG000	Group A: Deep Neuromuscular Blockade	An extra bolus of rocuronium after intubation followed by infusion Rocuronium: A bolus of 0.7 mg/kg rocuronium is administered just after tracheal intubation and then an infusion of rocuronium (0.3 to 0.4 mg/kg) is started when PTC is more than 0 and titrated towards PTC 1-2.
OG001	Group B: Moderate Neuromuscular Blockade	Moderate neuromuscular Blockade No additional rocuronium after intubation. No additional Rocuronium: No additional rocuronium is administered after tracheal intubation.

Units	Counts
Participants

Secondary

Postoperative Complications

Number of participants with postoperative complications that occurred up to 8 weeks after surgery

Posted

Count of Participants

Participants

24 and 48 hours (and if still admitted 72h) after detubation and 4 and 8 weeks after surgery

ID	Title	Description
OG000	Group A: Deep Neuromuscular Blockade	An extra bolus of rocuronium after intubation followed by infusion Rocuronium: A bolus of 0.7 mg/kg rocuronium is administered just after tracheal intubation and then an infusion of rocuronium (0.3 to 0.4 mg/kg) is started when PTC is more than 0 and titrated towards PTC 1-2.
OG001	Group B: Moderate Neuromuscular Blockade	Moderate neuromuscular Blockade No additional rocuronium after intubation. No additional Rocuronium: No additional rocuronium is administered after tracheal intubation.

Units	Counts
Participants	OG000

Secondary

Discharge Criteria

Scoring the following criteria: adequate pain control with oral medication, passage of flatus or defecation, intake of solid food tolerated, patient is mobilized and independent and patient accepts discharge.

Posted

Count of Participants

Participants

24 and 48 hours after detubation

ID	Title	Description
OG000	Group A: Deep Neuromuscular Blockade	An extra bolus of rocuronium after intubation followed by infusion Rocuronium: A bolus of 0.7 mg/kg rocuronium is administered just after tracheal intubation and then an infusion of rocuronium (0.3 to 0.4 mg/kg) is started when PTC is more than 0 and titrated towards PTC 1-2.
OG001	Group B: Moderate Neuromuscular Blockade	Moderate neuromuscular Blockade No additional rocuronium after intubation. No additional Rocuronium: No additional rocuronium is administered after tracheal intubation.

Units	Counts
Participants	OG000

Secondary

Pain Scores

Total amount of pain 4 weeks after surgery Likert scale from 0 to 10. Higher scores represent more pain (worse outcome).

Posted

Mean

Standard Deviation

score on a scale

once, 4 weeks after surgery

ID	Title	Description
OG000	Group A: Deep Neuromuscular Blockade	An extra bolus of rocuronium after intubation followed by infusion Rocuronium: A bolus of 0.7 mg/kg rocuronium is administered just after tracheal intubation and then an infusion of rocuronium (0.3 to 0.4 mg/kg) is started when PTC is more than 0 and titrated towards PTC 1-2.
OG001	Group B: Moderate Neuromuscular Blockade	Moderate neuromuscular Blockade No additional rocuronium after intubation. No additional Rocuronium: No additional rocuronium is administered after tracheal intubation.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Group A: Deep Neuromuscular Blockade	An extra bolus of rocuronium after intubation followed by infusion Rocuronium: A bolus of 0.7 mg/kg rocuronium is administered just after tracheal intubation and then an infusion of rocuronium (0.3 to 0.4 mg/kg) is started when PTC is more than 0 and titrated towards PTC 1-2.	0	48	0	48	9	48
EG001	Group B: Moderate Neuromuscular Blockade	Moderate neuromuscular Blockade No additional rocuronium after intubation. No additional Rocuronium: No additional rocuronium is administered after tracheal intubation.	0	48	1	48	5	48

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Urinary tract infection	Infections and infestations		Non-systematic Assessment		EG0000 events0 affected48 at risk EG0011 events1 affected48 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Urinary tract infection	Infections and infestations	Non-systematic Assessment	EG0006 events6 affected48 at risk EG0014 events4 affected48 at risk
Wound infection	Infections and infestations	Non-systematic Assessment	EG0002 events2 affected48 at risk EG0010 events0 affected48 at risk
Hypertension	General disorders	Non-systematic Assessment	EG0001 events1 affected48 at risk EG0011 events1 affected48 at risk

It appeared to be difficult to achieve and maintain the intended depth of neuromuscular blockade. Despite high dosages of rocuronium with continuous infusion, the intended deep NMB was not achieved in all patients within the deep NMB group.

Certain Agreements

ID	Term
D000077123	Rocuronium

Facility	Status	City	State	ZIP	Country	Contacts
LUMC		Leiden			Netherlands
Radboudumc

ID	Term
D000732	Androstanols
D000731	Androstanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds