Does Deep Neuromuscular Blockade Improve Operating Conditions During Total Hip Replacements?

• ClinicalTrials.gov Identifier: NCT03219294
• Recruitment Status: Completed
• First Posted: July 17, 2017
• Results First Posted: September 10, 2019
• Last Update Posted: September 18, 2019
• Sponsor: Craig Curry
• Collaborators: Maine Medical Center; Spectrum Medical Group Anesthesiology
• Information provided by (Responsible Party): Craig Curry, Maine Medical Center

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Other
• Condition: Arthropathy of Hip
• Interventions: Drug: Vecuronium 0.1 mg/kg; Drug: Vecuronium 0.2mg/kg
• Enrollment: 116

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Moderate NMB	Deep NMB
Arm/Group Description	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: 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.
Period Title: Overall Study
Started	58	58
Completed	58	58
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		Moderate NMB	Deep NMB	Total
Arm/Group Description		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: 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 of all reporting groups
Overall Number of Baseline Participants		58	58	116
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	58 participants	58 participants	116 participants
		63.1 (6.7)	62.9 (7.4)	63 (7.04)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	58 participants	58 participants	116 participants
	Female	29 50.0%	30 51.7%	59 50.9%
	Male	29 50.0%	28 48.3%	57 49.1%
Race and Ethnicity Not Collected [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	0 participants	0 participants	0 participants
				0
		[1] Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	58 participants	58 participants	116 participants
		58	58	116

Outcome Measures

1. Primary Outcome

Title	Surgical Conditions
Description	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).
Time Frame	Through study completion, an average of 24 hours.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Moderate NMB	Deep NMB
Arm/Group Description:	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: 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 Number of Participants Analyzed	58	58
Measure Type: Count of Participants; Unit of Measure: Participants
Extremely Poor Conditions	1 1.7%	2 3.4%
Poor Conditions	11 19.0%	10 17.2%
Acceptable Conditions	30 51.7%	29 50.0%
Good Conditions	15 25.9%	15 25.9%
Optimal Conditions	1 1.7%	2 3.4%

2. Secondary Outcome

Title	Duration of Surgery
Description	Time from incision to joint reduction
Time Frame	Through study completion, an average of 24 hours for each patient and up to one year for the whole study.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Moderate NMB	Deep NMB
Arm/Group Description:	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: 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 Number of Participants Analyzed	58	58
Mean (Standard Deviation); Unit of Measure: minutes
	32.6 (1.2)	33.8 (1.2)

Adverse Events

Time Frame	Patients were monitored for the duration of their surgical case and time in the post-anesthesia care unit until discharge from the hospital, usually 24 hours, and had a post-surgical follow-up several weeks after discharge.
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Moderate NMB	Deep NMB
Arm/Group Description	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: 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.
All-Cause Mortality
	Moderate NMB	Deep NMB
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/58 (0.00%)	0/58 (0.00%)
Serious Adverse Events
	Moderate NMB	Deep NMB
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/58 (0.00%)	0/58 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Moderate NMB	Deep NMB
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/58 (0.00%)	0/58 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Research Coordinator
• Organization: Maine Medical Center
• Phone: 2076622862
• EMail: richaj3@mmc.org

Publications:

Basad E, Ishaque B, Stürz H, Jerosch J. The anterolateral minimally invasive approach for total hip arthroplasty: technique, pitfalls, and way out. Orthop Clin North Am. 2009 Oct;40(4):473-8, viii. doi: 10.1016/j.ocl.2009.05.001. Review.

Brueckmann B, Sasaki N, Grobara P, Li MK, Woo T, de Bie J, Maktabi M, Lee J, Kwo J, Pino R, Sabouri AS, McGovern F, Staehr-Rye AK, Eikermann M. Effects of sugammadex on incidence of postoperative residual neuromuscular blockade: a randomized, controlled study. Br J Anaesth. 2015 Nov;115(5):743-51. doi: 10.1093/bja/aev104. Epub 2015 May 2.

Madsen MV, Staehr-Rye AK, Gätke MR, Claudius C. Neuromuscular blockade for optimising surgical conditions during abdominal and gynaecological surgery: a systematic review. Acta Anaesthesiol Scand. 2015 Jan;59(1):1-16. doi: 10.1111/aas.12419. Epub 2014 Oct 19. Review.

Paton F, Paulden M, Chambers D, Heirs M, Duffy S, Hunter JM, Sculpher M, Woolacott N. Sugammadex compared with neostigmine/glycopyrrolate for routine reversal of neuromuscular block: a systematic review and economic evaluation. Br J Anaesth. 2010 Nov;105(5):558-67. doi: 10.1093/bja/aeq269. Epub 2010 Oct 8. Review.

Chambers D, Paulden M, Paton F, Heirs M, Duffy S, Craig D, Hunter J, Wilson J, Sculpher M, Woolacott N. Sugammadex for the reversal of muscle relaxation in general anaesthesia: a systematic review and economic assessment. Health Technol Assess. 2010 Jul;14(39):1-211. doi: 10.3310/hta14390. Review.

• Responsible Party: Craig Curry, Maine Medical Center
• ClinicalTrials.gov Identifier: NCT03219294
• Other Study ID Numbers: 988210-2
• First Submitted: July 11, 2017
• First Posted: July 17, 2017
• Results First Submitted: August 19, 2019
• Results First Posted: September 10, 2019
• Last Update Posted: September 18, 2019