Trial Outcomes & Findings for Effect of Neuromuscular Block and Arterial PCO2 on Surgical Rating Scale (SRS), Following Reversal With Sugammadex (NCT NCT01968447)

NCT ID: NCT01968447

Last Updated: 2020-03-16

Results Overview

During a procedure, the surgical condition will be scored by one surgeon using a 5-point surgical rating scale. The rating scale is a 5-point ordinal scale ranging from 1 = poor condition to 5 = optimal surgical conditions. The surgeon will score the condition at 15 minute intervals.The values given on the surgical rating scale are averaged and the average value is used in the data analysis.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: Peroperative
• Results posted on: 2020-03-16

Participant Flow

Participant milestones

Measure	Hypocapnia arterial pCO2 of 3.5 kPa or 26.3 mmHg hypocapnia	Normocapnia arterial PCO2 of 6.5-7.0 kPa or 48.8-52.5 mmHg normocapnia
Overall Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Neuromuscular Block and Arterial PCO2 on Surgical Rating Scale (SRS), Following Reversal With Sugammadex

Baseline characteristics by cohort

Measure	Hypocapnia n=20 Participants arterial pCO2 of 3.5 kPa or 26.3 mmHg hypocapnia	Normocapnia n=20 Participants arterial PCO2 of 6.5-7.0 kPa or 48.8-52.5 mmHg normocapnia	Total n=40 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	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Age, Continuous	65 years n=5 Participants	62 years n=7 Participants	64 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	14 Participants n=7 Participants	31 Participants n=5 Participants
Region of Enrollment Netherlands	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: Peroperative

During a procedure, the surgical condition will be scored by one surgeon using a 5-point surgical rating scale. The rating scale is a 5-point ordinal scale ranging from 1 = poor condition to 5 = optimal surgical conditions. The surgeon will score the condition at 15 minute intervals.The values given on the surgical rating scale are averaged and the average value is used in the data analysis.

Outcome measures

Measure	Hypocapnia n=20 Participants arterial pCO2 of 3.5 kPa or 26.3 mmHg hypocapnia	Normocapnia n=20 Participants arterial PCO2 of 6.5-7.0 kPa or 48.8-52.5 mmHg normocapnia
Surgical Rating Scale	4.86 units on a scale Standard Deviation 0.4	4.75 units on a scale Standard Deviation 0.4

SECONDARY outcome

Timeframe: peroperative

Hemodynamic conditions are studied during low arterial CO2 concentration and normal arterial CO2 concentration. The average of the measured mean arterial pressures at 15 minute intervals during anesthesia are presented

Outcome measures

Measure	Hypocapnia n=20 Participants arterial pCO2 of 3.5 kPa or 26.3 mmHg hypocapnia	Normocapnia n=20 Participants arterial PCO2 of 6.5-7.0 kPa or 48.8-52.5 mmHg normocapnia
Hemodynamics	85 millimeters of mercury Standard Deviation 10	81 millimeters of mercury Standard Deviation 9

SECONDARY outcome

Timeframe: from the end of surgery untill 2 hours postoperative

The effect of low versus normal pCO2 concentrations on the postoperative respiratory function will be studied. Postoperative saturations are obtained at 15 minutes intervals. The data are averaged over time.

Outcome measures

Measure	Hypocapnia n=20 Participants arterial pCO2 of 3.5 kPa or 26.3 mmHg hypocapnia	Normocapnia n=20 Participants arterial PCO2 of 6.5-7.0 kPa or 48.8-52.5 mmHg normocapnia
Respiratory Function	98.6 percentage of oxygen saturation Standard Deviation 2.1	98.5 percentage of oxygen saturation Standard Deviation 2.0

SECONDARY outcome

Timeframe: from the end of surgery untill 2 hours postoperative

The effect of low versus normal pCO2 concentrations on postoperative pain will be studied. Painscores are obtained at 15 minutes intervals and are expressed as a number on a 10 point scale (numeric rating scale; 1 (low)-10(maximum)). The data is avaraged over time

Outcome measures

Measure	Hypocapnia n=20 Participants arterial pCO2 of 3.5 kPa or 26.3 mmHg hypocapnia	Normocapnia n=20 Participants arterial PCO2 of 6.5-7.0 kPa or 48.8-52.5 mmHg normocapnia
Pain Intensity on an 11-point Scale in the Postoperative Period	4.1 units on a scale Standard Deviation 3.3	4.0 units on a scale Standard Deviation 3.1

SECONDARY outcome

Timeframe: from the end of surgery untill 2 hours postoperative

The effect of low versus normal pCO2 concentrations on postoperative sedation will be studied using the using the validated Leiden Observer's Assessment of Alertness/Sedation (0 (awake) - 6 (unarousable)) scale at 15 min intervals. The data are averaged over time.

Outcome measures

Measure	Hypocapnia n=20 Participants arterial pCO2 of 3.5 kPa or 26.3 mmHg hypocapnia	Normocapnia n=20 Participants arterial PCO2 of 6.5-7.0 kPa or 48.8-52.5 mmHg normocapnia
Sedation	2.4 units on a scale Standard Deviation 0.9	2.3 units on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: from the end of surgery untill 2 hours postoperative

The effect of low versus normal pCO2 concentrations on the incidence of postoperative nausea will be studied. The incidence is expressed as the percentage of people experiencing nausea per arm.

Outcome measures

Measure	Hypocapnia n=20 Participants arterial pCO2 of 3.5 kPa or 26.3 mmHg hypocapnia	Normocapnia n=20 Participants arterial PCO2 of 6.5-7.0 kPa or 48.8-52.5 mmHg normocapnia
Nausea	3.6 percentage of patients	5.9 percentage of patients

SECONDARY outcome

Timeframe: from the end of surgery untill 2 hours postoperative

The effect of low versus normal pCO2 concentrations on the incidence of postoperative vomiting will be studied. The incidence of vomiting is expressed as a precentage of the patients per arm.

Outcome measures

Measure	Hypocapnia n=20 Participants arterial pCO2 of 3.5 kPa or 26.3 mmHg hypocapnia	Normocapnia n=20 Participants arterial PCO2 of 6.5-7.0 kPa or 48.8-52.5 mmHg normocapnia
Vomiting	0 percentage of patients	3.9 percentage of patients

Adverse Events

Hypocapnia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normocapnia

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

Albert Dahan

LUMC

Phone: +31 71 52 62301

Email: a.dahan@lumc.nl

Results disclosure agreements

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