Trial Outcomes & Findings for Propofol vs. Midazolam-based Balanced Propofol for Nonanesthesiologist Moderate Sedation in Colonoscopy (NCT NCT01428882)

Last Updated: 2016-05-25

Results Overview

Assessment every two minutes of the level of sedation during the endoscopic procedure, rating it as minimal, moderate or deep.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

135 participants

Primary outcome timeframe

Up to 1 hour after introduction of the colonoscope

Results posted on

2016-05-25

Participant Flow

Participant milestones

Participant milestones
Measure	Midazolam Balanced Propofol Sedation 2 mg midazolam in 2 ml saline midazolam followed by continuous propofol iv infusion Midazolam: Midazolam (5 mg/5 mL) 2 mg before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level	Single-agent Propofol Sedation 2 ml saline followed by continuous propofol iv infusion Propofol: Placebo (normal saline 2 ml) before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level
Overall Study STARTED	67	68
Overall Study COMPLETED	61	58
Overall Study NOT COMPLETED	6	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Midazolam Balanced Propofol Sedation 2 mg midazolam in 2 ml saline midazolam followed by continuous propofol iv infusion Midazolam: Midazolam (5 mg/5 mL) 2 mg before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level	Single-agent Propofol Sedation 2 ml saline followed by continuous propofol iv infusion Propofol: Placebo (normal saline 2 ml) before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level
Overall Study Lack of Efficacy	2	7
Overall Study Protocol Violation	4	3

Baseline Characteristics

Propofol vs. Midazolam-based Balanced Propofol for Nonanesthesiologist Moderate Sedation in Colonoscopy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Midazolam Balanced Propofol Sedation n=61 Participants 2 mg midazolam in 2 ml saline midazolam followed by continuous propofol iv infusion Midazolam: Midazolam (5 mg/5 mL) 2 mg before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level	Single-agent Propofol Sedation n=58 Participants 2 ml saline followed by continuous propofol iv infusion Propofol: Placebo (normal saline 2 ml) before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level	Total n=119 Participants Total of all reporting groups
Age, Continuous	58 years n=5 Participants	55 years n=7 Participants	56 years n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	30 Participants n=7 Participants	64 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	28 Participants n=7 Participants	55 Participants n=5 Participants
Body Mass Index	25.8 Kg/m2 STANDARD_DEVIATION 4.6 • n=5 Participants	25.1 Kg/m2 STANDARD_DEVIATION 3.5 • n=7 Participants	25.4 Kg/m2 STANDARD_DEVIATION 4.1 • n=5 Participants
Educational degree No degree	14 participants n=5 Participants	14 participants n=7 Participants	28 participants n=5 Participants
Educational degree High school	5 participants n=5 Participants	11 participants n=7 Participants	16 participants n=5 Participants
Educational degree Technical	20 participants n=5 Participants	10 participants n=7 Participants	30 participants n=5 Participants
Educational degree College	11 participants n=5 Participants	10 participants n=7 Participants	21 participants n=5 Participants
Educational degree Graduate degree	11 participants n=5 Participants	13 participants n=7 Participants	24 participants n=5 Participants
ASA class ASA 1	22 participants n=5 Participants	31 participants n=7 Participants	53 participants n=5 Participants
ASA class ASA 2	32 participants n=5 Participants	19 participants n=7 Participants	51 participants n=5 Participants
ASA class ASA 3	7 participants n=5 Participants	8 participants n=7 Participants	15 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 1 hour after introduction of the colonoscope

Assessment every two minutes of the level of sedation during the endoscopic procedure, rating it as minimal, moderate or deep.

Outcome measures

Outcome measures
Measure	Midazolam Balanced Propofol Sedation n=61 Participants 2 mg midazolam in 2 ml saline midazolam followed by continuous propofol iv infusion Midazolam: Midazolam (5 mg/5 mL) 2 mg before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level	Single-agent Propofol Sedation n=58 Participants 2 ml saline followed by continuous propofol iv infusion Propofol: Placebo (normal saline 2 ml) before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level
Level of Sedation Throughout the Entire Procedure Deep sedation at any point	22 participants	9 participants
Level of Sedation Throughout the Entire Procedure Deep sedation at minute 4	10 participants	1 participants
Level of Sedation Throughout the Entire Procedure Deep sedation at minute 6	12 participants	2 participants
Level of Sedation Throughout the Entire Procedure Deep sedation at minute 8	10 participants	3 participants

SECONDARY outcome

Timeframe: Up to 1 hour after colonoscopy

After completion of the procedure, the patient stood in the examination room monitored continuously by a nurse. When patients responded to normal verbal command, they were asked to sit up and were offered a drink. This was considered the early recovery time. If they were able to stand unassisted by the bed and had stable hemodynamics parameters (saturation\>90 % on room air and blood pressure and heart rate within 20 % of baseline), they were transferred to a locker room accompanied by a relative. The discharge criteria included ability to stand unassisted and tolerate clear liquids once dressed. Once a patient met discharge criteria, they were allowed to leave at their own discretion

Outcome measures

Outcome measures
Measure	Midazolam Balanced Propofol Sedation n=61 Participants 2 mg midazolam in 2 ml saline midazolam followed by continuous propofol iv infusion Midazolam: Midazolam (5 mg/5 mL) 2 mg before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level	Single-agent Propofol Sedation n=58 Participants 2 ml saline followed by continuous propofol iv infusion Propofol: Placebo (normal saline 2 ml) before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level
Duration of Recovery After the Endoscopic Procedure Early recovery time	6.8 minutes Interval 2.0 to 16.0	5.3 minutes Interval 2.0 to 13.0
Duration of Recovery After the Endoscopic Procedure Discharge time	10.4 minutes Interval 4.0 to 26.0	9.80 minutes Interval 2.0 to 30.0

SECONDARY outcome

Timeframe: Up to two hours, including colonoscopy performance and recovery period

The following events were considered complications of procedural sedation: a decline in oxygen saturation to less than 85 % longer than 30 s after increasing the oxygen flow rate to 5 L/min and transient propofol interruption, a heart rate less than 40 beats per minute and blood pressure less than 80/50 mmHg. Major complications were defined as need for mechanical ventilation or any cardiorespiratory event requiring anaesthesiologist assistance.

Outcome measures

Outcome measures
Measure	Midazolam Balanced Propofol Sedation n=61 Participants 2 mg midazolam in 2 ml saline midazolam followed by continuous propofol iv infusion Midazolam: Midazolam (5 mg/5 mL) 2 mg before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level	Single-agent Propofol Sedation n=58 Participants 2 ml saline followed by continuous propofol iv infusion Propofol: Placebo (normal saline 2 ml) before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level
Rate of Sedation-related Complications During the Procedure and the Recovery Phases Transient oxygen desaturation	5 participants	5 participants
Rate of Sedation-related Complications During the Procedure and the Recovery Phases Bradycardia	2 participants	1 participants
Rate of Sedation-related Complications During the Procedure and the Recovery Phases Arterial Hypotension	3 participants	2 participants

SECONDARY outcome

Timeframe: Up to 1 hour after colonoscopy for endoscopists and up to 48 hours for patients

Endoscopists and patients rated their satisfaction with sedation in a 10-cm visual analogue scale after discharge.The patients were contacted 24-48 h after the procedure to answer a questionnaire regarding if they remembered scope insertion or scope removal and willingness to repeat it with a similar protocol and rated their satisfaction and pain perception from 0 to 10. This phone survey was done by the nurse specifically making the measurements in the endoscopy room, who was blinded to the sedation regimen. For the interpretation of results of the 0-10 point numerical scale, 0 stands for 'extremely dissatisfied with sedation level during the endoscopic procedure', whereas 10 stands for 'extremely satisfied with sedation level during the endoscopic procedure".

Outcome measures

Outcome measures
Measure	Midazolam Balanced Propofol Sedation n=61 Participants 2 mg midazolam in 2 ml saline midazolam followed by continuous propofol iv infusion Midazolam: Midazolam (5 mg/5 mL) 2 mg before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level	Single-agent Propofol Sedation n=58 Participants 2 ml saline followed by continuous propofol iv infusion Propofol: Placebo (normal saline 2 ml) before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level
Rate of Patients and Physician Satisfaction With Sedation Endoscopist Satisfaction	8.9 units on a scale Interval 1.0 to 10.0	8.4 units on a scale Interval 1.0 to 10.0
Rate of Patients and Physician Satisfaction With Sedation Patient Satisfaction	9.8 units on a scale Interval 8.0 to 10.0	9.5 units on a scale Interval 5.0 to 10.0

Adverse Events

Midazolam Balanced Propofol Sedation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Single-agent Propofol Sedation

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. Javier Molina-Infante

Hospital San Pedro de Alcantara, Caceres

Phone: 0034927621543

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place