Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001451291
Ethics application status
Approved
Date submitted
18/08/2018
Date registered
28/08/2018
Date last updated
28/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of remifentanil and alfentanil efficacy in sedation for colonoscopy
Scientific title
Comparison of remifentanil and alfentanil combined with propofol/midazolam in sedation for colonoscopy
Secondary ID [1] 295831 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colonoscopy
ASA I-III patient 309276 0
Condition category
Condition code
Anaesthesiology 308150 308150 0 0
Anaesthetics
Oral and Gastrointestinal 308151 308151 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients aged over 18 years with ASA I-III who underwent colonoscopic examination for diagnosis and treatment under sedation with low dose of midazolam combined with Propofol/remifentanil and Propofol/alfentanil were included in the study. Patients aged under 18 years, having ASA IV-V and patients with opioid and/or sedative addictions, pregnancy, psychiatric/emotional disorder, patients undergoing an emergency or inpatient colonoscopy, and other endoscopic procedures in addition to colonoscopy were excluded from the study. Patients with incomplete procedure for any reason, and patients with inadequate bowel preparation were excluded from the final analysis.
Two hundred patients who underwent colonoscopy under sedation with the combination of remifentanil-propofol-midazolam or alfentanil-propofol-midazolam were included in the study. Eleven patients were excluded from the final analysis. The age, gender, body mass index (BMI), and American Anesthesiology Association physical status classification (ASA) of one hundred eighty-nine patients were recorded. All colonoscopy procedures were performed by the same experienced endoscopist using high resolution video colonoscopies (EC-530WL3, Fujinon, Fujifilm Corporation, Japan). All patients were monitored according to the ASA standards in the colonoscopy room. Heart rate (HR), mean arterial pressure (MAP), and peripheral oxygen saturation (SpO2) were measured and recorded (Petas KMA 800). Measurements were repeated every 5 minutes during the procedure. Intranasal oxygen (6 L/min) was administered to the patients. After peripheral intravenous cannulation, 6 ml/kg/hr normal saline infusion was initiated and 1 mg midazolam (1 mg/ml, 5 ml; Deva Holding, Istanbul, Turkey) was administered to all patients. Sedation was induced with 5µcg/kg alfentanil (Rapifen® Johnson & Johnson, Istanbul, Turkey) + 1 mg/kg propofol (Propofol, Fresenius, Istanbul, Turkey) in the alfentanil group (Group A), and 0.1 µcg/kg/min remifentanil (Ultiva, Glaxo Smith Kline, Istanbul, Turkey) + 1 mg/kg propofol in the remifentanil group (Group R). Propofol (10-20 mg) was added according to the Modified Steward Scale (MSS) in order to maintain at 2-4 .
Additional propofol doses were recorded. Pain level of the patients was assessed by visual analog scale (VAS) [no pain (0) - severe pain (10)] at every 5-minute interval during the colonoscopy procedure. Systolic blood pressure under 90 mmHg was accepted as hypotension and HR under 50 beats/min was accepted as bradycardia. Fluid infusion rate of patients who developed hypotension was increased by 3 folds. Additional fluid infusion was continued for 10 minutes. Vasopressor (ephedrine) administration was planned in patients who had no response to liquid infusion. Atropine (0.01 mg/kg; intravenous) was given to patients in case of bradycardia. SpO2 less than 90% was accepted as hypoxemia. When SpO2 was determined less than 90% during the follow up, jaw thrust maneuver was performed. If SpO2 persisted as less than 85% despite the jaw thrust maneuver, all of the infusions were stopped and assisted ventilation was performed. It was planned that, if SpO2 less than 85% took more than 30 seconds, then the procedure would be interrupted and an antagonist agent (flumazenil, naloxone) would be administered. Cardiopulmonary side effects (hypotension, bradycardia, and hypoxemia), nausea, vomiting, and the treatment were recorded in all patients. Colonoscopic procedure was waited for 60 seconds after the administration of the drugs. Total procedure time was defined as the time between the initiation and completion of colonoscopy. Awake time was defined as the time from the end of colonoscopy until Consciousness (0-4) score 4 according to the Modified Steward Scalasi (MSS), and the recovery time was defined as the time from the end of colonoscopy until Modified Aldrete Scoring (MAS) 10 was achieved. After the procedure, all patients were transferred to the recovery room and vital findings and MAS values were recorded. (MAS) which is a 10-point scale was used for assessing the recovery time . Patients were followed up until MAS 10 and then discharged.
Intervention code [1] 312166 0
Treatment: Drugs
Comparator / control treatment
remifentanil
Control group
Active

Outcomes
Primary outcome [1] 307124 0
awake times of low dose midazolam combined with propofol/alfentanil and propofol/remifentanil, in adult patients who underwent colonoscopy procedure.
Timepoint [1] 307124 0
Awake time was assessed with a Modified Steward Scale (MSS) every 5 minutes throughout the procedure (approximately 20 minutes).
Primary outcome [2] 307125 0
recovery times of low dose midazolam combined with propofol/alfentanil and propofol/remifentanil, in adult patients who underwent colonoscopy procedure.
Timepoint [2] 307125 0
recovery time was assessed every 5 minutes with Modified Aldrete Scores at the end of the procedure (approximately 15 minutes).
Primary outcome [3] 307151 0
additional propofol dose of low dose midazolam combined with propofol/alfentanil and propofol/remifentanil, in adult patients who underwent colonoscopy procedure.
Timepoint [3] 307151 0
additional propofol dose calculated at the end of the procedure
Secondary outcome [1] 350766 0
Side effects that occurred during sedation were evaluated from medical records.
Timepoint [1] 350766 0
Cardiopulmonary side effects (hypotension, bradycardia, and hypoxemia), nausea, vomiting, and the treatment were recorded in all patients. These side effects were assessed as the duration of the procedure (approximately 20 minutes) and post-procedure (approximately 15 minutes).

Eligibility
Key inclusion criteria
Patients aged over 18 years with ASA I-III who underwent colonoscopic examination for diagnosis and treatment under sedation with low dose of midazolam combined with Propofol/remifentanil and Propofol/alfentanil were included in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients aged under 18 years, having ASA IV-V and patients with opioid and/or sedative addictions, pregnancy, psychiatric/emotional disorder, patients undergoing an emergency or inpatient colonoscopy, and other endoscopic procedures in addition to colonoscopy were excluded from the study.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Data obtained were analyzed using SPSS 20.00 software (Statistical Package for Social Sciences Inc Chicago, IL). The continuous variables are expressed as mean ± SD or number (%). Whereas categorical variables are expressed as number and percentages (%). Normality of the data was tested with Kolmogorov Smirnov. Since there was no normal distribution, continuous variables were analyzed with Mann Whitney U test. Comparison of two groups and analysis of categorical variables were made using Chi-Square test. P values < 0.05 were considered statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
4/12/2017
Date of last participant enrolment
Anticipated
Actual
11/05/2018
Date of last data collection
Anticipated
Actual
17/07/2018
Sample size
Target
200
Accrual to date
Final
189
Recruitment outside Australia
Country [1] 20792 0
Turkey
State/province [1] 20792 0
Konya

Funding & Sponsors
Funding source category [1] 300427 0
University
Name [1] 300427 0
Necmettin Erbakan University Medical Faculty
Country [1] 300427 0
Turkey
Primary sponsor type
University
Name
Necmettin Erbakan University Medical Faculty
Address
Yunus Emre Mah. Baglarbasi Sok. No;281 42080 Meram- KONYA
Country
Turkey
Secondary sponsor category [1] 299889 0
None
Name [1] 299889 0
Address [1] 299889 0
Country [1] 299889 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301231 0
Necmettin Erbakan University, Department of Medical Ethics
Ethics committee address [1] 301231 0
Ethics committee country [1] 301231 0
Turkey
Date submitted for ethics approval [1] 301231 0
29/11/2017
Approval date [1] 301231 0
01/12/2017
Ethics approval number [1] 301231 0
2017/1109

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86310 0
Dr Arican Sule
Address 86310 0
University of Necmettin Erbakan, Medical Faculty,Yunus Emre Mah. Baglarbasi Sok. No;281 42080 Meram-KONYA
Country 86310 0
Turkey
Phone 86310 0
00903322236600
Fax 86310 0
Email 86310 0
[email protected]
Contact person for public queries
Name 86311 0
Tuncer Uzun Sema
Address 86311 0
University of Necmettin Erbakan, Medical Faculty,Yunus Emre Mah. Baglarbasi Sok. No;281 42080 Meram-KONYA
Country 86311 0
Turkey
Phone 86311 0
00903322236600
Fax 86311 0
Email 86311 0
[email protected]
Contact person for scientific queries
Name 86312 0
Tuncer Uzun Sema
Address 86312 0
University of Necmettin Erbakan, Medical Faculty,Yunus Emre Mah. Baglarbasi Sok. No;281 42080 Meram-KONYA
Country 86312 0
Turkey
Phone 86312 0
00903322236600
Fax 86312 0
Email 86312 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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