Propofol sedation during diagnostic colonoscopy

• Register: ISRCTN
• Last refreshed on: 28 May 2018
• Main ID: ISRCTN51098340
• Date of registration: 14/09/2015
• Prospective Registration: No
• Primary sponsor: Institutional Ethics Committee of the Clinical Center of Serbia
• Public title: Propofol sedation during diagnostic colonoscopy
• Scientific title: Manually versus target controlled infusion in balanced propofol sedation during diagnostic colonoscopy: a prospective randomized controlled trial
• Date of first enrolment: 01/04/2013
• Target sample size: 90
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN51098340
• Study type: Interventional
• Study design: Single-centre interventional prospective randomised parallel trial (Treatment)

Countries of recruitment

Serbia

Contacts

• Name: Vera Vucicevic

Key inclusion & exclusion criteria

Inclusion criteria: 1. Aged between 18 and 65 years old
2. Body weight from 50 to 120 kg
3. Classified to groups I (normal, healthy patient) or II (mild systemic disease) according to the American Society of Anesthesiologists
4. Scheduled for diagnostic outpatient colonoscopy with deep sedation
Exclusion criteria: 1. Allergy to the study drugs
2. Previous problems with anesthesia or sedation
3. History of stridor snoring or sleep apnea
4. Neck abnormalites
5. Those classified to groups III or IV of Mallampati classification.

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Patients undergoing a colonoscopy
Not Applicable
Patients undergoing a colonoscopy

Intervention(s)

In the endoscopy room intravenous access is obtained and each patient received 8 ml/kg/h of isotonic saline solution in the form of infusion and 100% oxygen is supplemented with a mask (6 L/min). Pre-induction medication for all patients is as follows: midazolam (Dormicum, Roche Pharma, Reinach, Switzerland 5 mg/5ml) in a bolus of 2 mg for the patients up to 70 kg, and 3 mg for those over 70 kg, and fentanyl (Fentanyl, Janssen-Cilag, Baar, Switzerland 0.05 mg/ml) in a bolus of 1ml for the patients between 50 and 60 kg, 1.5 ml for the patients between 60 and 80 kg, and 2 ml for those over 80 kg. Both drugs were administrated slowly (> 60 seconds), 2 minutes before propofol. The patients in the manual titration group (n=45) receive propofol intravenously (Diprivan, Astra-Zeneca, Stocholm, Sweden 10 mg/ml), in a bolus of 0.5 mg/kg, and then 10-20 mg are titrated every 1 to 2 minutes. The target-controlled infusion (TCI) group (n=45) receive propofol with TCI pump (Alaris PK, Cardinal Health), according to the Schnider’s pharmacokinetic model, with the initial Ce of 2.5 µg/ml. This concentration is increased or decreased for 0.5-1 µg/ml until the desired level of sedation was achieved. Administration of propofol is stopped at the end of the colonoscopy.
The patients are monitored at 5-minute intervals: the heart rate is measured automatically as well as the blood oxygen saturation (SpO2) using pulse oximeter (Drager, Oxipac); systolic (SAP) and diastolic (DAP) arterial pressure are measured manually in serial manner, then mean arterial blood pressure (MAP) is calculated and respiration rate per minute is recorded (RR). The Modified Observer’s Assesment of Alertness/Sedation (MOAA/S) scale (12) is used to document the patients responsiveness scores. The patients who lose response to verbal commands and eyelash reflex (MOAA/S = 2) are considered to be unconscious.

Primary Outcome(s)

Adverse events between the two treatment areas monitored throughout the study:
1. Mean arterial blood pressure < 60 mmHg (hypotension) or > 105 mmHg (hypertension
2. Heart rate < 45 beats/min (bradycardia) or > 115 beats/min (tachycardia)
3. Blood oxygen desaturation < 92% for longer than 30 sec (hypoxemia)
4. Number of respirations <6/min (bradypnea) or 0 (apnea)
5.Any other advenrse effects (e.g. coughing, hiccupping)

Secondary Outcome(s)

After the procedure, the comfort of the endoscopist is measured using the following:
1. Assessing the difficulty of colonoscopy with 11-point (0-10) and with verbal Numerical Pain Rating Scale (NRS)
2. Difficulty of the experience on the scale, with 0 being “not difficult at all” and 10 “the most difficult experience imaginable”
3. Assessment of patients' sedation using verbal scale for the quality of sedation from 1-4 (1-excellent, 2-good, 3-fair, 4-poor)
4. Assessment of patients' comfort based on the observation of defensive reactions during colonoscopy
5. Overall satisfaction with procedure using verbal scale for comfort from 1-5 (1-excellent, 2-very good, 3-good, 4-fair, 5-poor).

Secondary ID(s)

N/A

Source(s) of Monetary Support

Clinical Center of Serbia

Ethics review

Status:
Approval date:
Contact:

Institutional Ethics Committee of the Clinical Centre of Serbia, 01/08/2012, ref: 4183/01.08.2012

Results

• Results available: Yes
• Date Completed: 25/10/2014