Trial Outcomes & Findings for Efficacy and Safety Profiles of Combination Sedation Propofol With Midazolam and Meperidine. (NCT NCT01709422)

Results Overview

(1) induction time ( the time from sedation to scope intubation ), (2) procedure time ( the time from scope intubation to scope withdrawal ) and (3) recovery time ( the time from scope withdrawal to full recovery ).The induction time, procedural time and recovery time were recorded by the nurse in the endoscopy unit.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

140 participants

Primary outcome timeframe

participants will be followed for the duration of procedure, an expected average of 2.0 hours ]

Results posted on

2013-10-22

Participant Flow

Patients who were schedule for endoscopic retrograde cholangiopancreatography in NKC Institute ,Prince of Songkla University during January 2010-December 2011

Patients were excluded from the final analysis if the procedure was terminated due to technical reasons prior to attempted cannulation.

Participant milestones

Participant milestones
Measure	Propofol The propofol was given as initial bolus of 20 mg and then the dose was given 5-10 mg every 30-60 second.the dose of midazolam was 1 mg in patients below 70 years and 0.5 mg in patients ≥ 70 years and the dose of meperidine was fixed at 20 mg.	Conventional The initial dose of midazolam and meperidine were 2-5 mg iv and 25-50 mg iv respectively then the midazolam dose was given 0.5-1.0 mg iv and meperidine dose was given 5-10 mg iv every 2-3 minutes
Overall Study STARTED	70	70
Overall Study COMPLETED	70	70
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety Profiles of Combination Sedation Propofol With Midazolam and Meperidine.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Propofol,Midazolam and Meperidine n=70 Participants The propofol was given as initial bolus of 20 mg and then the dose was given 5-10 mg every 30-60 second.the dose of midazolam was 1 mg in patients below 70 years and 0.5 mg in patients ≥ 70 years and the dose of meperidine was fixed at 20 mg.	Midazolam and Meperidine n=70 Participants The initial dose of midazolam and meperidine were 2-5 mg iv and 25-50 mg iv respectively then the midazolam dose was given 0.5-1.0 mg iv and meperidine dose was given 5-10 mg iv every 2-3 minutes	Total n=140 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	47 Participants n=5 Participants	37 Participants n=7 Participants	84 Participants n=5 Participants
Age, Categorical >=65 years	23 Participants n=5 Participants	33 Participants n=7 Participants	56 Participants n=5 Participants
Age Continuous	55.77 years STANDARD_DEVIATION 17.35 • n=5 Participants	61.31 years STANDARD_DEVIATION 16.52 • n=7 Participants	58.54 years STANDARD_DEVIATION 17.11 • n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants	34 Participants n=7 Participants	72 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	36 Participants n=7 Participants	68 Participants n=5 Participants
Region of Enrollment Thailand	70 participants n=5 Participants	70 participants n=7 Participants	140 participants n=5 Participants

PRIMARY outcome

Timeframe: participants will be followed for the duration of procedure, an expected average of 2.0 hours ]

Population: Intention to treat population include participants who received sedative agents and underwent endoscopic retrograde cholangiopancreatography(ERCP).

(1) induction time ( the time from sedation to scope intubation ), (2) procedure time ( the time from scope intubation to scope withdrawal ) and (3) recovery time ( the time from scope withdrawal to full recovery ).The induction time, procedural time and recovery time were recorded by the nurse in the endoscopy unit.

Outcome measures

Outcome measures
Measure	Propofol,Midazolam and Meperidine n=70 Participants the dose of midazolam was 1 mg in patients below 70 years and 0.5 mg in patients ≥ 70 years and the dose of meperidine was fixed at 20 mg. The propofol was given as initial bolus of 20 mg and then the dose was given 5-10 mg every 30-60 second to maintained the desired level of sedation(moderate to deep sedation ) without maximum limit.	Midazolam and Meperidine n=70 Participants the initial dose of midazolam and meperidine were 2-5 mg iv and 25-50 mg iv respectively then the midazolam dose was given 0.5-1.0 mg iv and meperidine dose was given 5-10 mg iv every 2-3 minutes to maintain the desired level of sedation(moderate to deep sedation ) without maximum limit.
Procedure Related Time procedure time	40.67 minutes Standard Deviation 27.50	43.24 minutes Standard Deviation 31.35
Procedure Related Time induction time	3.94 minutes Standard Deviation 2.18	5.47 minutes Standard Deviation 2.51
Procedure Related Time recovery time	24.71 minutes Standard Deviation 23.03	88.50 minutes Standard Deviation 54.62

SECONDARY outcome

Timeframe: participants will be followed for the duration of procedure, an expected average of 2.0 hours

Population: Intention to treat population include participants who received sedative agents and underwent ERCP.

(1) desaturation(oxygen saturation \< 90 % at least 10 second ) (2) hypotension ( systolic blood pressure \< 90 mmHg or dropped more than 25 % of baseline ) (3)bradycardia (heart rate \< 50 beats/min) and (4) apnea ( cessation of respiratory activity for over 10 seconds ). When patients developed oxygen saturation \< 90 %, then nasal oxygen was administered, If patients not able to recover from oxygen therapy and tactile stimulations thus the procedure was terminated. The procedure was terminated if patients developed serious adverse event as heart rate below 5 beats/min and or apnea.

Outcome measures

Outcome measures
Measure	Propofol,Midazolam and Meperidine n=70 Participants the dose of midazolam was 1 mg in patients below 70 years and 0.5 mg in patients ≥ 70 years and the dose of meperidine was fixed at 20 mg. The propofol was given as initial bolus of 20 mg and then the dose was given 5-10 mg every 30-60 second to maintained the desired level of sedation(moderate to deep sedation ) without maximum limit.	Midazolam and Meperidine n=70 Participants the initial dose of midazolam and meperidine were 2-5 mg iv and 25-50 mg iv respectively then the midazolam dose was given 0.5-1.0 mg iv and meperidine dose was given 5-10 mg iv every 2-3 minutes to maintain the desired level of sedation(moderate to deep sedation ) without maximum limit.
Cardiovascular Adverse Events. Participants with desatuartion	26 Participants	40 Participants
Cardiovascular Adverse Events. Participants with hypotension	12 Participants	14 Participants
Cardiovascular Adverse Events. Participants with bradycardia	1 Participants	0 Participants

Adverse Events

Propofol,Midazolam and Meperidine

Serious events: 1 serious events

Other events: 26 other events

Deaths: 0 deaths

Midazolam and Meperidine

Serious events: 0 serious events

Other events: 40 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Propofol,Midazolam and Meperidine n=70 participants at risk The propofol was given as initial bolus of 20 mg and then the dose was given 5-10 mg every 30-60 second.the dose of midazolam was 1 mg in patients below 70 years and 0.5 mg in patients ≥ 70 years and the dose of meperidine was fixed at 20 mg.	Midazolam and Meperidine n=70 participants at risk The initial dose of midazolam and meperidine were 2-5 mg iv and 25-50 mg iv respectively then the midazolam dose was given 0.5-1.0 mg iv and meperidine dose was given 5-10 mg iv every 2-3 minutes
Cardiac disorders Severe bradycardia	1.4% 1/70 • Number of events 1 • 1 month ERCP complications and sedation related complications are assessed one month after the procedure date.	0.00% 0/70 • 1 month ERCP complications and sedation related complications are assessed one month after the procedure date.

Other adverse events

Other adverse events
Measure	Propofol,Midazolam and Meperidine n=70 participants at risk The propofol was given as initial bolus of 20 mg and then the dose was given 5-10 mg every 30-60 second.the dose of midazolam was 1 mg in patients below 70 years and 0.5 mg in patients ≥ 70 years and the dose of meperidine was fixed at 20 mg.	Midazolam and Meperidine n=70 participants at risk The initial dose of midazolam and meperidine were 2-5 mg iv and 25-50 mg iv respectively then the midazolam dose was given 0.5-1.0 mg iv and meperidine dose was given 5-10 mg iv every 2-3 minutes
Respiratory, thoracic and mediastinal disorders Hypoxia	37.1% 26/70 • Number of events 26 • 1 month ERCP complications and sedation related complications are assessed one month after the procedure date.	57.1% 40/70 • Number of events 40 • 1 month ERCP complications and sedation related complications are assessed one month after the procedure date.

Additional Information

Dr. Nisa Netinatsunton

Prince of Songkhla University

Phone: 6674451965

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place