Trial Outcomes & Findings for Effect of Neuromuscular Blockade on Operating Conditions and Overall Satisfaction During Spinal Surgery (NCT NCT02724111)

NCT ID: NCT02724111

Last Updated: 2017-10-13

Results Overview

This outcome is the mean value of the peak inspiratory pressure measured at each 15 minute during the anesthesia, which can reflect the degree of the tone of respiratory muscles. As muscle tone increases, airway pressure usually increases due to increased tone of abdominal muscle and respiratory muscles including diaphragm. The longer the surgery goes, the higher the airway pressure gets. Also, as neurospinal surgeries are operated in the prone position, the potential for increased airway pressure is high. As airway pressure gets higher, intrathoracic pressure and intraabdominal pressure also become higher. These consequences may bring about similar results with detrimental effects derived from marked increase in intraabdominal pressure in laparoscopic abdominal surgeries

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 90 participants
• Primary outcome timeframe: Every 15 minutes during anesthesia, up to 3 hours
• Results posted on: 2017-10-13

Participant Flow

This study was a single-site study recruited and performed at Korea University Guro Hospital, a general hospital, Seoul, South Korea, from 15 May 2016 to 16 February 2017.

No enrolled participants were excluded from the study before assignment to arms or groups.

Participant milestones

Measure	Deep Neuromuscular Blockade This arm will be given sufficient dose of rocuronium. In this Arm group, rocuronium will be administered to maintain deep neuromuscular blockade \[NMB\] (train-of-four \[TOF\] count 0, post-tetanic count \[PTC\] of 1-2 twitches) until the end of surgery and the reversal of NMB will be performed by sugammadex 4 mg/kg at the end of surgery'. sufficient dose of rocuronium	Restricted Neuromuscular Blockade This arm will be given restricted (not sufficient) dose of rocuronium. In this Arm group, sugammadex will be administered according to the prescribing indications (4 mg/kg for deep neuromuscular blockade \[NMB\] state or 2 mg/kg for moderate NMB or less) to reverse the NMB 10 min after position change (sugammadex 10 min after position change \[a prone position\]). Thereafter, muscle relaxants will not be injected any more throughout the surgery except the following situations: If the patients show any body movement during surgery or if surgeons express any complaint about muscle tone (the muscle tone: grade 3), rescue rocuronium 5 mg will be administered and the number of body movements and rescue rocuronium administration (dose) will be recorded. sugammadex 10 min after position change
Overall Study STARTED	45	45
Overall Study COMPLETED	43	40
Overall Study NOT COMPLETED	2	5

Reasons for withdrawal

Measure	Deep Neuromuscular Blockade This arm will be given sufficient dose of rocuronium. In this Arm group, rocuronium will be administered to maintain deep neuromuscular blockade \[NMB\] (train-of-four \[TOF\] count 0, post-tetanic count \[PTC\] of 1-2 twitches) until the end of surgery and the reversal of NMB will be performed by sugammadex 4 mg/kg at the end of surgery'. sufficient dose of rocuronium	Restricted Neuromuscular Blockade This arm will be given restricted (not sufficient) dose of rocuronium. In this Arm group, sugammadex will be administered according to the prescribing indications (4 mg/kg for deep neuromuscular blockade \[NMB\] state or 2 mg/kg for moderate NMB or less) to reverse the NMB 10 min after position change (sugammadex 10 min after position change \[a prone position\]). Thereafter, muscle relaxants will not be injected any more throughout the surgery except the following situations: If the patients show any body movement during surgery or if surgeons express any complaint about muscle tone (the muscle tone: grade 3), rescue rocuronium 5 mg will be administered and the number of body movements and rescue rocuronium administration (dose) will be recorded. sugammadex 10 min after position change
Overall Study Protocol Violation	2	5

Baseline Characteristics

Effect of Neuromuscular Blockade on Operating Conditions and Overall Satisfaction During Spinal Surgery

Baseline characteristics by cohort

Measure	Deep Neuromuscular Blockade n=43 Participants This arm will be given sufficient dose of rocuronium. In this Arm group, rocuronium will be administered to maintain deep neuromuscular blockade \[NMB\] (TOF count 0, post-tetanic count \[PTC\] of 1-2 twitches) until the end of surgery and the reversal of NMB will be performed by sugammadex 4 mg/kg at the end of surgery'. sufficient dose of rocuronium	Restricted Neuromuscular Blockade n=40 Participants This arm will be given restricted (not sufficient) dose of rocuronium. In this Arm group, sugammadex will be administered according to the prescribing indications (4 mg/kg for deep neuromuscular blockade \[NMB\] state or 2 mg/kg for moderate NMB or less) to reverse the NMB 10 min after position change (sugammadex 10 min after position change \[a prone position\]). Thereafter, muscle relaxants will not be injected any more throughout the surgery except the following situations: If the patients show any body movement during surgery or if surgeons express any complaint about muscle tone (the muscle tone: grade 3), rescue rocuronium 5 mg will be administered and the number of body movements and rescue rocuronium administration (dose) will be recorded. sugammadex 10 min after position change	Total n=83 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants	31 Participants n=7 Participants	61 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants	9 Participants n=7 Participants	22 Participants n=5 Participants
Age, Continuous	61 years n=5 Participants	60 years n=7 Participants	60 years n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	29 Participants n=7 Participants	60 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Race/Ethnicity, Customized Korean	43 Participants n=5 Participants	40 Participants n=7 Participants	83 Participants n=5 Participants
Region of Enrollment South Korea	43 Participants n=5 Participants	40 Participants n=7 Participants	83 Participants n=5 Participants
Height (m)	1.59 meter STANDARD_DEVIATION 0.07 • n=5 Participants	1.58 meter STANDARD_DEVIATION 0.08 • n=7 Participants	1.59 meter STANDARD_DEVIATION 0.07 • n=5 Participants
Weight (kg)	59.8 kg STANDARD_DEVIATION 8.5 • n=5 Participants	60 kg STANDARD_DEVIATION 6.9 • n=7 Participants	59.9 kg STANDARD_DEVIATION 7.7 • n=5 Participants

PRIMARY outcome

Timeframe: Every 15 minutes during anesthesia, up to 3 hours

This outcome is the mean value of the peak inspiratory pressure measured at each 15 minute during the anesthesia, which can reflect the degree of the tone of respiratory muscles. As muscle tone increases, airway pressure usually increases due to increased tone of abdominal muscle and respiratory muscles including diaphragm. The longer the surgery goes, the higher the airway pressure gets. Also, as neurospinal surgeries are operated in the prone position, the potential for increased airway pressure is high. As airway pressure gets higher, intrathoracic pressure and intraabdominal pressure also become higher. These consequences may bring about similar results with detrimental effects derived from marked increase in intraabdominal pressure in laparoscopic abdominal surgeries

Outcome measures

Measure	Deep Neuromuscular Blockade n=43 Participants This arm will be given sufficient dose of rocuronium. In this Arm group, rocuronium will be administered to maintain deep neuromuscular blockade \[NMB\] (TOF count 0, post-tetanic count \[PTC\] of 1-2 twitches) until the end of surgery and the reversal of NMB will be performed by sugammadex 4 mg/kg at the end of surgery'. sufficient dose of rocuronium	Restricted Neuromuscular Blockade n=40 Participants This arm will be given restricted (not sufficient) dose of rocuronium. In this Arm group, sugammadex will be administered according to the prescribing indications (4 mg/kg for deep neuromuscular blockade \[NMB\] state or 2 mg/kg for moderate NMB or less) to reverse the NMB 10 min after position change (sugammadex 10 min after position change \[a prone position\]). Thereafter, muscle relaxants will not be injected any more throughout the surgery except the following situations: If the patients show any body movement during surgery or if surgeons express any complaint about muscle tone (the muscle tone: grade 3), rescue rocuronium 5 mg will be administered and the number of body movements and rescue rocuronium administration (dose) will be recorded. sugammadex 10 min after position change
Mean Value of Peak Inspiratory Pressure	18.4 cmH2O Standard Deviation 1.1	20.2 cmH2O Standard Deviation 1.1

SECONDARY outcome

Timeframe: Every 15 minutes at the period of the retractor placement during surgery, up to 2 hours

Mean value of pressure of back muscle retractor placed in the operating site (recorded every 15 minutes during the placement of the retractor): measured by the pressure probe placed between the retractor and the back muscle.

Outcome measures

Measure	Deep Neuromuscular Blockade n=43 Participants This arm will be given sufficient dose of rocuronium. In this Arm group, rocuronium will be administered to maintain deep neuromuscular blockade \[NMB\] (TOF count 0, post-tetanic count \[PTC\] of 1-2 twitches) until the end of surgery and the reversal of NMB will be performed by sugammadex 4 mg/kg at the end of surgery'. sufficient dose of rocuronium	Restricted Neuromuscular Blockade n=40 Participants This arm will be given restricted (not sufficient) dose of rocuronium. In this Arm group, sugammadex will be administered according to the prescribing indications (4 mg/kg for deep neuromuscular blockade \[NMB\] state or 2 mg/kg for moderate NMB or less) to reverse the NMB 10 min after position change (sugammadex 10 min after position change \[a prone position\]). Thereafter, muscle relaxants will not be injected any more throughout the surgery except the following situations: If the patients show any body movement during surgery or if surgeons express any complaint about muscle tone (the muscle tone: grade 3), rescue rocuronium 5 mg will be administered and the number of body movements and rescue rocuronium administration (dose) will be recorded. sugammadex 10 min after position change
Mean Value of Pressure of Back Muscle Retractor	81.2 mmHg Standard Deviation 9.1	100 mmHg Standard Deviation 7.3

SECONDARY outcome

Timeframe: After surgery

Overall satisfaction of surgeons for the surgical condition will be assessed by the surgeons who perform surgery using numerical rating scale (NRS; 1-10) after surgery (1, worst; 10, best).

Outcome measures

Measure	Deep Neuromuscular Blockade n=43 Participants This arm will be given sufficient dose of rocuronium. In this Arm group, rocuronium will be administered to maintain deep neuromuscular blockade \[NMB\] (TOF count 0, post-tetanic count \[PTC\] of 1-2 twitches) until the end of surgery and the reversal of NMB will be performed by sugammadex 4 mg/kg at the end of surgery'. sufficient dose of rocuronium	Restricted Neuromuscular Blockade n=40 Participants This arm will be given restricted (not sufficient) dose of rocuronium. In this Arm group, sugammadex will be administered according to the prescribing indications (4 mg/kg for deep neuromuscular blockade \[NMB\] state or 2 mg/kg for moderate NMB or less) to reverse the NMB 10 min after position change (sugammadex 10 min after position change \[a prone position\]). Thereafter, muscle relaxants will not be injected any more throughout the surgery except the following situations: If the patients show any body movement during surgery or if surgeons express any complaint about muscle tone (the muscle tone: grade 3), rescue rocuronium 5 mg will be administered and the number of body movements and rescue rocuronium administration (dose) will be recorded. sugammadex 10 min after position change
Overall Satisfaction of Surgeons for the Surgical Condition	8 Scores on a scale (NRS; 1-10) Standard Deviation 1.3	3.1 Scores on a scale (NRS; 1-10) Standard Deviation 1.2

SECONDARY outcome

Timeframe: at the screw insertion through the pedicle of spine during surgery

The muscle tone of each patient at the screw insertion through the pedicle of spine during surgery scaled by surgeons (1: muscle tone is good, suitable for surgery; 2: muscle tone is moderate, but do not affect the operation; 3: muscle tone is hard, making the operation difficult.).

Outcome measures

Measure	Deep Neuromuscular Blockade n=43 Participants This arm will be given sufficient dose of rocuronium. In this Arm group, rocuronium will be administered to maintain deep neuromuscular blockade \[NMB\] (TOF count 0, post-tetanic count \[PTC\] of 1-2 twitches) until the end of surgery and the reversal of NMB will be performed by sugammadex 4 mg/kg at the end of surgery'. sufficient dose of rocuronium	Restricted Neuromuscular Blockade n=40 Participants This arm will be given restricted (not sufficient) dose of rocuronium. In this Arm group, sugammadex will be administered according to the prescribing indications (4 mg/kg for deep neuromuscular blockade \[NMB\] state or 2 mg/kg for moderate NMB or less) to reverse the NMB 10 min after position change (sugammadex 10 min after position change \[a prone position\]). Thereafter, muscle relaxants will not be injected any more throughout the surgery except the following situations: If the patients show any body movement during surgery or if surgeons express any complaint about muscle tone (the muscle tone: grade 3), rescue rocuronium 5 mg will be administered and the number of body movements and rescue rocuronium administration (dose) will be recorded. sugammadex 10 min after position change
The Muscle Tone	1.3 Scores on a scale (NRS; 1-3) Standard Deviation 0.7	2.5 Scores on a scale (NRS; 1-3) Standard Deviation 0.7

SECONDARY outcome

Timeframe: At the occurrence of the event during surgery, up to 3 hours

The number of body movements (including cough or any diaphragm movement) observed during the surgery.

Outcome measures

Measure	Deep Neuromuscular Blockade n=43 Participants This arm will be given sufficient dose of rocuronium. In this Arm group, rocuronium will be administered to maintain deep neuromuscular blockade \[NMB\] (TOF count 0, post-tetanic count \[PTC\] of 1-2 twitches) until the end of surgery and the reversal of NMB will be performed by sugammadex 4 mg/kg at the end of surgery'. sufficient dose of rocuronium	Restricted Neuromuscular Blockade n=40 Participants This arm will be given restricted (not sufficient) dose of rocuronium. In this Arm group, sugammadex will be administered according to the prescribing indications (4 mg/kg for deep neuromuscular blockade \[NMB\] state or 2 mg/kg for moderate NMB or less) to reverse the NMB 10 min after position change (sugammadex 10 min after position change \[a prone position\]). Thereafter, muscle relaxants will not be injected any more throughout the surgery except the following situations: If the patients show any body movement during surgery or if surgeons express any complaint about muscle tone (the muscle tone: grade 3), rescue rocuronium 5 mg will be administered and the number of body movements and rescue rocuronium administration (dose) will be recorded. sugammadex 10 min after position change
The Number of Body Movements	0 number of event Standard Deviation 0	2 number of event Standard Deviation 1

SECONDARY outcome

Timeframe: Continuously observed during the whole period of surgery, up to 3 hours

2.The degree of bleeding of each patient scaled by surgeons (Intraoperative scale for assessment of operating condition of surgical field: 0 - No bleeding, 1 - Slight bleeding - no suctioning of blood required, 2 - Slight bleeding - occasional suctioning required but not threatened the operative field, 3 - Slight-bleeding - frequent suctioning of blood was required that threatens the operative field a few seconds after suctioning, 4 - Moderate bleeding - frequent suctioning of blood was required which threatens the operative field directly after suctioning, 5 - Severe bleeding - continuous suctioning of blood was required which severely threatened the operative field make the surgery not possible).

Outcome measures

Measure	Deep Neuromuscular Blockade n=43 Participants This arm will be given sufficient dose of rocuronium. In this Arm group, rocuronium will be administered to maintain deep neuromuscular blockade \[NMB\] (TOF count 0, post-tetanic count \[PTC\] of 1-2 twitches) until the end of surgery and the reversal of NMB will be performed by sugammadex 4 mg/kg at the end of surgery'. sufficient dose of rocuronium	Restricted Neuromuscular Blockade n=40 Participants This arm will be given restricted (not sufficient) dose of rocuronium. In this Arm group, sugammadex will be administered according to the prescribing indications (4 mg/kg for deep neuromuscular blockade \[NMB\] state or 2 mg/kg for moderate NMB or less) to reverse the NMB 10 min after position change (sugammadex 10 min after position change \[a prone position\]). Thereafter, muscle relaxants will not be injected any more throughout the surgery except the following situations: If the patients show any body movement during surgery or if surgeons express any complaint about muscle tone (the muscle tone: grade 3), rescue rocuronium 5 mg will be administered and the number of body movements and rescue rocuronium administration (dose) will be recorded. sugammadex 10 min after position change
The Degree of Bleeding	1.8 Scores on a scale (NRS; 0-5) Standard Deviation 0.7	3.3 Scores on a scale (NRS; 0-5) Standard Deviation 0.7

SECONDARY outcome

Timeframe: every 10 min for 1 hour at PACU.

the time to reach sedation score 5 (the Observer's Assessment of Alertness/ Sedation (OAA/S) score; awake, 5 to unresponsive, 1) at PACU

Outcome measures

Measure	Deep Neuromuscular Blockade n=43 Participants This arm will be given sufficient dose of rocuronium. In this Arm group, rocuronium will be administered to maintain deep neuromuscular blockade \[NMB\] (TOF count 0, post-tetanic count \[PTC\] of 1-2 twitches) until the end of surgery and the reversal of NMB will be performed by sugammadex 4 mg/kg at the end of surgery'. sufficient dose of rocuronium	Restricted Neuromuscular Blockade n=40 Participants This arm will be given restricted (not sufficient) dose of rocuronium. In this Arm group, sugammadex will be administered according to the prescribing indications (4 mg/kg for deep neuromuscular blockade \[NMB\] state or 2 mg/kg for moderate NMB or less) to reverse the NMB 10 min after position change (sugammadex 10 min after position change \[a prone position\]). Thereafter, muscle relaxants will not be injected any more throughout the surgery except the following situations: If the patients show any body movement during surgery or if surgeons express any complaint about muscle tone (the muscle tone: grade 3), rescue rocuronium 5 mg will be administered and the number of body movements and rescue rocuronium administration (dose) will be recorded. sugammadex 10 min after position change
Recovery Time (Time to Reach Sedation Score 5 at Postanesthesia Care Unit (PACU).	10.5 minute Standard Deviation 7.9	17 minute Standard Deviation 11.4

SECONDARY outcome

Timeframe: during the postoperative 24 hours

The occurrence of any adverse events was recorded in the post-anesthesia care unit (PACU) and a ward during the postoperative 24 hours.

Outcome measures

Measure	Deep Neuromuscular Blockade n=43 Participants This arm will be given sufficient dose of rocuronium. In this Arm group, rocuronium will be administered to maintain deep neuromuscular blockade \[NMB\] (TOF count 0, post-tetanic count \[PTC\] of 1-2 twitches) until the end of surgery and the reversal of NMB will be performed by sugammadex 4 mg/kg at the end of surgery'. sufficient dose of rocuronium	Restricted Neuromuscular Blockade n=40 Participants This arm will be given restricted (not sufficient) dose of rocuronium. In this Arm group, sugammadex will be administered according to the prescribing indications (4 mg/kg for deep neuromuscular blockade \[NMB\] state or 2 mg/kg for moderate NMB or less) to reverse the NMB 10 min after position change (sugammadex 10 min after position change \[a prone position\]). Thereafter, muscle relaxants will not be injected any more throughout the surgery except the following situations: If the patients show any body movement during surgery or if surgeons express any complaint about muscle tone (the muscle tone: grade 3), rescue rocuronium 5 mg will be administered and the number of body movements and rescue rocuronium administration (dose) will be recorded. sugammadex 10 min after position change
Adverse Events : The Postoperative Nausea and Vomiting Occurrence in Subject	11 Participants	8 Participants

Adverse Events

Deep Neuromuscular Blockade

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Restricted Neuromuscular Blockade

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Deep Neuromuscular Blockade n=43 participants at risk This arm will be given sufficient dose of rocuronium. In this Arm group, rocuronium will be administered to maintain deep neuromuscular blockade \[NMB\] (TOF count 0, post-tetanic count \[PTC\] of 1-2 twitches) until the end of surgery and the reversal of NMB will be performed by sugammadex 4 mg/kg at the end of surgery'. sufficient dose of rocuronium	Restricted Neuromuscular Blockade n=40 participants at risk This arm will be given restricted (not sufficient) dose of rocuronium. In this Arm group, sugammadex will be administered according to the prescribing indications (4 mg/kg for deep neuromuscular blockade \[NMB\] state or 2 mg/kg for moderate NMB or less) to reverse the NMB 10 min after position change (sugammadex 10 min after position change \[a prone position\]). Thereafter, muscle relaxants will not be injected any more throughout the surgery except the following situations: If the patients show any body movement during surgery or if surgeons express any complaint about muscle tone (the muscle tone: grade 3), rescue rocuronium 5 mg will be administered and the number of body movements and rescue rocuronium administration (dose) will be recorded. sugammadex 10 min after position change
Gastrointestinal disorders nausea or vomiting	25.6% 11/43 • during the postoperative 24 hours Same.	20.0% 8/40 • during the postoperative 24 hours Same.

Additional Information

Dr Byung Gun Lim

Korea University Guro Hospital

Phone: 82-2-2626-1437

Email: bglim9205@korea.ac.kr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place