Trial Outcomes & Findings for Effectiveness of Deep Versus Moderate Neuromuscular Blockade (NCT NCT03266419)

Results Overview

The patient was administered intravenous oxycodone 2 mg (body weight \<80 kg) or 3 mg (\>80 kg) every 10 min until the VAS (visual analogue scale)assessments showed that the pain intensity had decreased to \<3 at rest and \<5 on wound compression. At this point, MEAD of oxycodone was determined. The range of VAS is 0-10 (0 = no pain; 10 = most severe pain).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

100 participants

Primary outcome timeframe

Through study period in PACU (post anesthesia care unit), up to 2 hours

Results posted on

2019-11-13

Participant Flow

Participant milestones

Participant milestones
Measure	Deep NMB Using Rocuronium The abdomen is insufflated to 13 mmHg pneumoperitoneum with deep NMB (post tetanic count 1-2) during operation Deep NMB using rocuronium: - Drug: rocuronium * Bolus dose: 0.7 mg/kg * Continuous infusion : 0.8-1.2 mg/kg/h for maintaining deep NMB (post tetanic count 1-2) during operation.	Moderate NMB Using Rocuronium The abdomen is insufflated to 13 mmHg pneumoperitoneum with moderate NMB (train of four 1-2) during operation Moderate NMB using rocuronium: - Drug: rocuronium * Bolus dose: none * Continuous infusion: 0.2-0.6 mg/kg/h for maintaining moderate NMB (train of four 1-2) during operation.
Overall Study STARTED	51	49
Overall Study COMPLETED	51	49
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	Deep NMB Using Rocuronium n=51 Participants The abdomen is insufflated to 13 mmHg pneumoperitoneum with deep NMB (post tetanic count 1-2) during operation Deep NMB using rocuronium: - Drug: rocuronium * Bolus dose: 0.7 mg/kg * Continuous infusion : 0.8-1.2 mg/kg/h for maintaining deep NMB (post tetanic count 1-2) during operation.	Moderate NMB Using Rocuronium n=49 Participants The abdomen is insufflated to 13 mmHg pneumoperitoneum with moderate NMB (train of four 1-2) during operation Moderate NMB using rocuronium: - Drug: rocuronium * Bolus dose: none * Continuous infusion: 0.2-0.6 mg/kg/h for maintaining moderate NMB (train of four 1-2) during operation.	Total n=100 Participants Total of all reporting groups
Age, Continuous	58 years n=51 Participants	58 years n=49 Participants	58 years n=100 Participants
Sex: Female, Male Female	16 Participants n=51 Participants	16 Participants n=49 Participants	32 Participants n=100 Participants
Sex: Female, Male Male	35 Participants n=51 Participants	33 Participants n=49 Participants	68 Participants n=100 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment South Korea	51 participants n=51 Participants	49 participants n=49 Participants	100 participants n=100 Participants
Duration of pneumoperitoneum	117.0 minute n=51 Participants	102.0 minute n=49 Participants	109 minute n=100 Participants

PRIMARY outcome

Timeframe: Through study period in PACU (post anesthesia care unit), up to 2 hours

Population: patients undergoing elective laparoscopic gastrectomy

The patient was administered intravenous oxycodone 2 mg (body weight \<80 kg) or 3 mg (\>80 kg) every 10 min until the VAS (visual analogue scale)assessments showed that the pain intensity had decreased to \<3 at rest and \<5 on wound compression. At this point, MEAD of oxycodone was determined. The range of VAS is 0-10 (0 = no pain; 10 = most severe pain).

Outcome measures

Outcome measures
Measure	Deep NMB Using Rocuronium n=51 Participants The abdomen is insufflated to 13 mmHg pneumoperitoneum with deep NMB (post tetanic count 1-2) during operation Deep NMB using rocuronium: - Drug: rocuronium * Bolus dose: 0.7 mg/kg * Continuous infusion : 0.8-1.2 mg/kg/h for maintaining deep NMB (post tetanic count 1-2) during operation.	Moderate NMB Using Rocuronium n=49 Participants The abdomen is insufflated to 13 mmHg pneumoperitoneum with moderate NMB (train of four 1-2) during operation Moderate NMB using rocuronium: - Drug: rocuronium * Bolus dose: none * Continuous infusion: 0.2-0.6 mg/kg/h for maintaining moderate NMB (train of four 1-2) during operation.
Minimum Effective Analgesic Dose (MEAD) of Oxycodone at Postoperative Care Unit (PACU)	8.0 mg Interval 2.0 to 26.0	8.0 mg Interval 2.0 to 27.0

SECONDARY outcome

Timeframe: Through study period in post anesthesia care unit (PACU), an average of about 1 hour

Population: patients undergoing elective laparoscopic gastrectomy

The patient was administered intravenous oxycodone 2 mg (body weight \<80 kg) or 3 mg (\>80 kg) every 10 min until the visual analogue scale (VAS) assessments showed that the pain intensity had decreased to \<3 at rest and \<5 on wound compression. At this point, the minimum effective analgesic dose (MEAD) of oxycodone was determined. The range of VAS is 0-10 (0 = no pain; 10 = most severe pain).

Outcome measures

Outcome measures
Measure	Deep NMB Using Rocuronium n=51 Participants The abdomen is insufflated to 13 mmHg pneumoperitoneum with deep NMB (post tetanic count 1-2) during operation Deep NMB using rocuronium: - Drug: rocuronium * Bolus dose: 0.7 mg/kg * Continuous infusion : 0.8-1.2 mg/kg/h for maintaining deep NMB (post tetanic count 1-2) during operation.	Moderate NMB Using Rocuronium n=49 Participants The abdomen is insufflated to 13 mmHg pneumoperitoneum with moderate NMB (train of four 1-2) during operation Moderate NMB using rocuronium: - Drug: rocuronium * Bolus dose: none * Continuous infusion: 0.2-0.6 mg/kg/h for maintaining moderate NMB (train of four 1-2) during operation.
Mean Visual Analogue Scale (VAS) Score for Wound Pain at Post Anesthesia Care Unit (PACU)	6.1 mm Interval 2.8 to 8.4	6.1 mm Interval 2.7 to 7.3

Adverse Events

Deep NMB Using Rocuronium

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Moderate NMB Using Rocuronium

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

Dr. Byung-Moon Choi

Asan Medical Center

Phone: 82-2-3010-1704

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place