Colonoscopy
Conditions
Keywords
TCI propofol, PCS propofol, sedation, colonoscopy
Brief summary
This was a prospective, randomized, single-blind controlled clinical trial comparing three sedative regimens for outpatient colonoscopy.
Detailed description
This was a prospective, randomized, single-blind controlled clinical trial comparing target-controlled infusion (TCI) with propofol and patient-controlled sedation (PCS) with propofol, to conventional combination of midazolam and pethidine, in terms of quality and safety of sedation, and patient recovery during outpatient colonoscopy.
Interventions
DRUGMidazolam injection
DEVICEtarget controlled infusion pump
DEVICEpatient-controlled sedation pump
Sponsors
Universiti Kebangsaan Malaysia Medical Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* ASA I or II patients * aged between 18 to 80 years * scheduled for outpatient colonoscopy
Exclusion criteria
* history of or with psychiatric disease * on psychoactive drugs * mentally or physically unable to use the hand-held device for PCS * previous complications from anaesthesia or sedation * potentially difficult airway maintenance * obstructive sleep apnoea * pregnant * with contraindications to the study drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient willingness to repeat the same sedation technique | From patient arrival to recovery post colonoscopy, area until the point of patient discharge, assessed up to 3 hours after arrival at recovery | Patient responds yes or no. to willingness of having the same sedation during colonoscopy, in the future |
| Recovery time to Modified Observer's Assessment of Alertness and Sedation Scale (MOAAS) | From time of arrival at the recovery area after completion of colonoscopy, until point of discharge from recovery area, assessed up to 2 hours post arrival at recovery | Recovery of patient from sedation when MOAAS 5 is achieved |
| Recovery time to ambulation | From time of arrival at the recovery area after completion of colonoscopy, until the point patient starts to ambulate, assessed up to 2 hours post arrival at recovery | Recovery of patient from sedation when patient starts ambulating |
| Recovery time to discharge | From time of arrival at the recovery area after completion of colonoscopy, until the point patient is deemed fit for discharge home, assessed up to 2 hours post arrival at recovery | Recovery of patient from sedation when patient is deemed fit for discharge home |
| Endoscopist satisfaction score | After completion of colonoscopy, the endoscopist graded his satisfaction score from the start of colonoscopy, assessed until 2 hours after completion of colonoscopy | After completion of colonoscopy, the endoscopist graded on a scale of 1 to 10, ease of the colonoscopy/procedure (1 = very difficult, 10 = very easy), and level of satisfaction (1 = very dissatisfied, 10 = very satisfied) using a 10 cm visual analog scale (VAS). |
| Patient satisfaction score | Patient satisfaction score from start of sedation until point of discharge from recovery assessed until 3 hours from the start of sedation | After completion of colonoscopy, the patient graded on a scale of 1 to 10, the level of satisfaction (1 = very dissatisfied, 10 = very satisfied) using a 10 cm visual analog scale (VAS). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rescue analgesic drug requirement | From start of sedation, and during the entire duration of colonoscopy, assessed up to 2 hours from the start of sedation | Requirement for rescue analgesic or sedative in addition to study drugs/sedatives, during the entire duration of colonoscopy |
| Total drug consumption | Total consumption of all study drugs from the start of sedation, during the entire duration of colonoscopy until completion of colonoscopy, assessed up to 2 hours from the start of sedation | Total consumption of all study drugs from the start of sedation, during the entire duration of colonoscopy until completion of colonoscopy |
| Ease of colonoscopy score | during the entire duration of colonoscopy from the start of colonoscopy, assessed up to 2 hours from the start of colonoscopy | endoscopist graded on a scale of 1 to 10, ease of procedure (1 = very difficult, 10 = very easy) |
| Recalled events during colonoscopy | Recalled events retrieved from patient, from arrival to recovery area until point of discharge home, assessed up to 2 hours from arrival at recovery | The number of recalled events during the entire duration of colonoscopy |
| Recalled discomfort/ pain during colonoscopy | Recalled events of discomfort/pain retrived from the patient, from arrival to recovery area until point of discharge home, assessed up to 2 hours from arrival at recovery | The number of recalled events of discomfor/pain during the entire duration of colonoscopy |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time taken to onset of sedation | From start of sedation until MOAAS 3 or 4 attained, assessed up to one hour from the point sedation was commenced | Time taken for patient to reach a sedation score of MOAAS 3 or 4 |
Countries
Malaysia
Outcome results
None listed