Trial Outcomes & Findings for Does Deep Neuromuscular Blockade Improve Operating Conditions During Total Hip Replacements? (NCT NCT03219294)

Results Overview

The surgeon graded the overall surgical conditions on a 5 point Likert scale, that was taken into account along with requests for additional muscle relaxation. The Likert scale went from 1 (extremely poor conditions: muscles resistant to retraction and obscure view, implant difficult to insert into socket, requires assist) to 5 (optimal conditions: muscles relaxed, excellent view, implant easy to insert).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

116 participants

Primary outcome timeframe

Through study completion, an average of 24 hours.

Results posted on

2019-09-18

Participant Flow

Participant milestones

Participant milestones
Measure	Moderate NMB Intubating dose of Vecuronium 0.1 mg/kg (IBW) and re-dosing with 0.0125 to 0.05 mg/kg as needed to achieve and maintain 1 to 2 TOF contractions. Redosing in this manner is a current clinical practice. Vecuronium 0.1 mg/kg: Vecuronium will be administered to achieve and maintain 1 to 2 TOF contractions.	Deep NMB Deep NMB: Intubating dose of Vecuronium 0.2 mg/kg (IBW) and re-dosing with 0.025 to 0.1 mg/kg to achieve and maintain zero twitches in the TOF, and post tetanic count (PTC) of 1 to 2 contractions. This level of blockade is new to the practice since approval of the drug for use at MMC but is in common use since the advent of Sugammadex. Vecuronium 0.2mg/kg: Vecuronium will be administered to achieve and 0 TOF/PTC 1-2.
Overall Study STARTED	58	58
Overall Study COMPLETED	58	58
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Moderate NMB n=58 Participants Intubating dose of Vecuronium 0.1 mg/kg (IBW) and re-dosing with 0.0125 to 0.05 mg/kg as needed to achieve and maintain 1 to 2 TOF contractions. Redosing in this manner is a current clinical practice. Vecuronium 0.1 mg/kg: Vecuronium will be administered to achieve and maintain 1 to 2 TOF contractions.	Deep NMB n=58 Participants Deep NMB: Intubating dose of Vecuronium 0.2 mg/kg (IBW) and re-dosing with 0.025 to 0.1 mg/kg to achieve and maintain zero twitches in the TOF, and post tetanic count (PTC) of 1 to 2 contractions. This level of blockade is new to the practice since approval of the drug for use at MMC but is in common use since the advent of Sugammadex. Vecuronium 0.2mg/kg: Vecuronium will be administered to achieve and 0 TOF/PTC 1-2.	Total n=116 Participants Total of all reporting groups
Age, Continuous	63.1 years STANDARD_DEVIATION 6.7 • n=58 Participants	62.9 years STANDARD_DEVIATION 7.4 • n=58 Participants	63 years STANDARD_DEVIATION 7.04 • n=116 Participants
Sex: Female, Male Female	29 Participants n=58 Participants	30 Participants n=58 Participants	59 Participants n=116 Participants
Sex: Female, Male Male	29 Participants n=58 Participants	28 Participants n=58 Participants	57 Participants n=116 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	58 participants n=58 Participants	58 participants n=58 Participants	116 participants n=116 Participants

PRIMARY outcome

Timeframe: Through study completion, an average of 24 hours.

The surgeon graded the overall surgical conditions on a 5 point Likert scale, that was taken into account along with requests for additional muscle relaxation. The Likert scale went from 1 (extremely poor conditions: muscles resistant to retraction and obscure view, implant difficult to insert into socket, requires assist) to 5 (optimal conditions: muscles relaxed, excellent view, implant easy to insert).

Outcome measures

Outcome measures
Measure	Moderate NMB n=58 Participants Intubating dose of Vecuronium 0.1 mg/kg (IBW) and re-dosing with 0.0125 to 0.05 mg/kg as needed to achieve and maintain 1 to 2 TOF contractions. Redosing in this manner is a current clinical practice. Vecuronium 0.1 mg/kg: Vecuronium will be administered to achieve and maintain 1 to 2 TOF contractions.	Deep NMB n=58 Participants Deep NMB: Intubating dose of Vecuronium 0.2 mg/kg (IBW) and re-dosing with 0.025 to 0.1 mg/kg to achieve and maintain zero twitches in the TOF, and post tetanic count (PTC) of 1 to 2 contractions. This level of blockade is new to the practice since approval of the drug for use at MMC but is in common use since the advent of Sugammadex. Vecuronium 0.2mg/kg: Vecuronium will be administered to achieve and 0 TOF/PTC 1-2.
Surgical Conditions Extremely Poor Conditions	1 Participants	2 Participants
Surgical Conditions Poor Conditions	11 Participants	10 Participants
Surgical Conditions Acceptable Conditions	30 Participants	29 Participants
Surgical Conditions Good Conditions	15 Participants	15 Participants
Surgical Conditions Optimal Conditions	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Through study completion, an average of 24 hours for each patient and up to one year for the whole study.

Time from incision to joint reduction

Outcome measures

Outcome measures
Measure	Moderate NMB n=58 Participants Intubating dose of Vecuronium 0.1 mg/kg (IBW) and re-dosing with 0.0125 to 0.05 mg/kg as needed to achieve and maintain 1 to 2 TOF contractions. Redosing in this manner is a current clinical practice. Vecuronium 0.1 mg/kg: Vecuronium will be administered to achieve and maintain 1 to 2 TOF contractions.	Deep NMB n=58 Participants Deep NMB: Intubating dose of Vecuronium 0.2 mg/kg (IBW) and re-dosing with 0.025 to 0.1 mg/kg to achieve and maintain zero twitches in the TOF, and post tetanic count (PTC) of 1 to 2 contractions. This level of blockade is new to the practice since approval of the drug for use at MMC but is in common use since the advent of Sugammadex. Vecuronium 0.2mg/kg: Vecuronium will be administered to achieve and 0 TOF/PTC 1-2.
Duration of Surgery	32.6 minutes Standard Deviation 1.2	33.8 minutes Standard Deviation 1.2

Adverse Events

Moderate NMB

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Deep NMB

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Research Coordinator

Maine Medical Center

Phone: 2076622862

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place