Trial Outcomes & Findings for Propofol Administered by Gastroenterologists by Target Controlled Infusion Pump During Endoscopy (NCT NCT02062177)

Results Overview

Visual Analog Scale from 0 to100 (0=dissatisfaction - 100=complete satisfaction) will be used to assess the technical difficulty of examination and the satisfaction with sedation of patient experienced by endoscopist

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

140 participants

Primary outcome timeframe

at the end of the exam

Results posted on

2014-09-08

Participant Flow

140 consecutive outpatients were scheduled to undergo Upper Endoscopy (70 patients) or complete Colonoscopy (70 patients) from 17 th February 2014 to 5 th May 2014 in Endoscopy Unit of San Raffaele Hospital - Milan.

Exclusion criteria were: significant systemic disease (ASA III-IV), allergic reactions to study drugs, chronic use of opioids, psychiatric disorders, pregnancy, difficult airways (Mallampati score \>2), age \<18 years. A gastroenterology attending fellow (GF), not directly involved in the procedure, provided sedation.

Participant milestones

Participant milestones
Measure	Propofol Group A total amount of 70 patients (35 undergoing upper endoscopy + 35 undergoing colonoscopy) were sedated with propofol TCI (Target Controlled Infusion) pump. Target concentration was initially set at 1.2-1.6 µg/ml according to patient's body weight and general condition. 35 patients of the group undergoing colonoscopy received also iv fentanyl (1μg/Kg) for pain control.	Midazolam Group A total amount of 70 patients (35 undergoing upper endoscopy + 35 undergoing colonoscopy) were sedated with midazolam (0.04 mg/kg if aged \<70 years - 0.03 mg/kg if aged \>70 years). 35 patients of the group undergoing colonoscopy received also iv fentanyl (1μg/Kg) for pain control.
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

Propofol Administered by Gastroenterologists by Target Controlled Infusion Pump During Endoscopy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Propofol Group n=70 Participants 70 patients (35 undergoing upper endoscopy + 35 undergoing colonoscopy) were sedated with propofol TCI (Target Controlled Infusion) pump. Target concentration was initially set at 1.2-1.6 µg/ml according to patient's body weight and general condition. 35 patients of the group undergoing colonoscopy received also iv fentanyl (1μg/Kg) for pain control. Patients in this group received placebo boluses with normal saline to warrant blindness to the randomization group of both patient and endoscopist. (because of the well-known difference in the physical appearance of the study drugs, to maintain blindness of endoscopist, a fabric curtain was drawn across patient's arm covering the i.v. line and TCI pump).	Midazolam Group n=70 Participants 70 patients (35 undergoing upper endoscopy + 35 undergoing colonoscopy) were sedated with midazolam (0.04 mg/kg if aged \<70 years - 0.03 mg/kg if aged \>70 years). 35 patients of the group undergoing colonoscopy received also iv fentanyl (1μg/Kg) for pain control.	Total n=140 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	55 Participants n=93 Participants	57 Participants n=4 Participants	112 Participants n=27 Participants
Age, Categorical >=65 years	15 Participants n=93 Participants	13 Participants n=4 Participants	28 Participants n=27 Participants
Sex: Female, Male Female	30 Participants n=93 Participants	32 Participants n=4 Participants	62 Participants n=27 Participants
Sex: Female, Male Male	40 Participants n=93 Participants	38 Participants n=4 Participants	78 Participants n=27 Participants
Region of Enrollment Italy	70 participants n=93 Participants	70 participants n=4 Participants	140 participants n=27 Participants

PRIMARY outcome

Timeframe: at the end of the exam

Visual Analog Scale from 0 to100 (0=dissatisfaction - 100=complete satisfaction) will be used to assess the technical difficulty of examination and the satisfaction with sedation of patient experienced by endoscopist

Outcome measures

Outcome measures
Measure	Propofol Group; n=35, 35 n=70 Participants	Midazolam Group; n=35, 35 n=70 Participants
Endoscopist's Satisfaction (Visual Analog Scale) About Sedation upper endoscopy	93 units on a scale Standard Deviation 14	83 units on a scale Standard Deviation 21
Endoscopist's Satisfaction (Visual Analog Scale) About Sedation colonoscopy	98 units on a scale Standard Deviation 11	87 units on a scale Standard Deviation 12

PRIMARY outcome

Timeframe: before discharge

When completely awake, patients will be asked to rate the degree of pain/discomfort and the degree of satisfaction about quality of sedation from 0 to100 (0=dissatisfaction - 100=complete satisfaction)

Outcome measures

Outcome measures
Measure	Propofol Group; n=35, 35 n=70 Participants	Midazolam Group; n=35, 35 n=70 Participants
Patient's Satisfaction (Visual Analog Scale) About Sedation Before Discharge Upper endoscopy	94 units on a scale Standard Deviation 18	76 units on a scale Standard Deviation 25
Patient's Satisfaction (Visual Analog Scale) About Sedation Before Discharge Colonoscopy	95 units on a scale Standard Deviation 9	85 units on a scale Standard Deviation 14

PRIMARY outcome

Timeframe: at 24-72 hours after procedure

Patients will be contacted by telephone 24-72 hours after discharge and asked about their satisfaction about the quality of sedation, rated on a verbal rating scale, from 0 to 100 (0=dissatisfaction; 100=complete satisfaction)

Outcome measures

Outcome measures
Measure	Propofol Group; n=35, 35 n=70 Participants	Midazolam Group; n=35, 35 n=70 Participants
Patient's Satisfaction (Visual Analog Scale) About Sedation 24-72 Hours After Procedure Upper endoscopy	93 units on a scale Standard Deviation 20	77 units on a scale Standard Deviation 27
Patient's Satisfaction (Visual Analog Scale) About Sedation 24-72 Hours After Procedure Colonoscopy	97 units on a scale Standard Deviation 9	88 units on a scale Standard Deviation 16

SECONDARY outcome

Timeframe: one day

After endoscopy, patients will be transferred to recovery area and evaluated every 5 minutes until they will be ready to be discharged from the Endoscopy Unit. Recovery will be assessed using the Modified Aldrete Scoring System; patients will be considered fit for discharge with a Modified Aldrete Scoring System score of 18 or more, stable vital signs and without nausea, vomiting, or itching.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: one day

Number of patients with adverse events (hypotension, bradycardia, hypoxemia,...)

Outcome measures

Outcome data not reported

Adverse Events

Propofol Group; n=35, 35

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Midazolam Group; n=35, 35

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

Professor Testoni Pier Alberto

Università Vita-Salute San Raffaele

Phone: +390226432756

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place