Propofol sedation during diagnostic colonoscopy

Manually versus target controlled infusion in balanced propofol sedation during diagnostic colonoscopy: a prospective randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN51098340

Enrollment

Registered

2015-09-14

Start date

2013-04-01

Completion date

Unknown

Last updated

2018-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients undergoing a colonoscopy Not Applicable Patients undergoing a colonoscopy

Interventions

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-

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). Th

Eligibility

Sex/Gender

All

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
Adverse events between the two treatment areas monitored throughout the study: 1. Mean arterial blood pressure 105 mmHg (hypertension 2. Heart rate 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

Measure	Time frame
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).	—

Measure

Time frame

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).

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Countries

Serbia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026