Diagnostic Colonoscopy ScreeningPhase 4remifentanilNCT01693185
Remifentanil Only vs. Midazolam and Meperidine During Elective Colonoscopy
A Phase 4 study testing Remifentanil, Midazolam and Meperidine in people with Diagnostic Colonoscopy Screening, run by Konkuk University Medical Center at 1 site in South Korea.
Trial summary
The aim of the present study is to compare patient's recovery times after elective colonoscopy employing remifentanil only vs conventional combination of midazolam and meperidine Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Diagnostic Colonoscopy Screening
- What is being tested?
- Remifentanil, Midazolam and Meperidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2012to Aug 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 19-65 years
- American Society of Anesthesiologists physical status (ASA PS) 1-2
- Patients scheduled for elective colonoscopy under Monitored Anesthesia Care in a University Hospital
- Patients who signed on written informed consent.
Who cannot join
- The exclusion criteria are refusal or inability to provide written informed consent
- Age < 18 years
- Pregnancy
- Previous large bowel surgery
- Psychiatric disorders
- History of addiction to opiates and / or sedatives, and previous adverse reaction to any drug used in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Remifentanil Only vs. Combination Group Midazolam + Meperidine During Elective Colonoscopy
The aim of the present study is to compare patient's recovery times after elective colonoscopy employing remifentanil only vs conventional combination of midazolam and meperidine
Read the detailed description
A regimen with combined administration of midazolam and meperidine has been widely used and provides quite satisfactory sedation as well as analgesia during colonoscopy. However, the relatively long duration of midazolam and meperidine often prolongs the recovery time after colonoscopy and delays discharge time. (Reimann FM , Samson U , Derad I et al. Synergistic sedation with low-dose midazolam and propofol for colonoscopies . Endoscopy 2000 ; 32 : 239 - 44).
Remifentanil, an ultra-short-acting opioid, provides excellent pain control during colonoscopy and its rapid onset and offset times are advantages over other conventional opioids including meperidine, in avoiding prolonged discharge time after the colonoscopy.
A total 54 patients, aged 18-65 years in American Society of Anesthesiologists physical status (ASA PS)1 and 2, scheduled for elective colonoscopy under Monitored Anesthesia Care in a University Hospital, will be recruited after obtaining written informed consent during the patients' first visit to outpatient/inpatient clinic for interview.
Predetermined patient identification numbers (PIN) and enrolment order were placed in sealed envelopes, and all patients were randomly assigned, at recruitment, to the midazolam-meperidine combination (group-MM) or remifentanil alone (group-R). If a patient was excluded during the study, the following patient assumed the status of the excluded patient.
Patients are allocated into one of two groups, Group 1 and Group 2 (27 patients each) according to the PIN at the recruitment.
The exclusion criteria were as follows: refusal or inability to provide written informed consent, age <19 years, pregnancy, previous history of large bowel surgery, a psychiatric disorder, an addictions to opiates or sedatives, a previous history of adverse events to any drug used in the present study, and performance of any additional diagnostic procedure after completion of colonoscopy.
All colonoscopic procedure is going to be performed by one Gastroenterologist (endoscopist).
On arriving in the endoscopy room, supplemental oxygen (2 L/min) was given through the mouth and both nostrils via a specially designed nasal prong which could monitor the end-tidal CO2 (ETCO2) level.
Before drug administration, the basal values of mean blood pressure (MBP), heart rate (HR), peripheral O2 saturation (SpO2), respiratory rate (RR), end-expiratory CO2 level (ETCO2), and the bispectral index (BIS), were recorded by a single observer, who also monitored these values every 5 min during entire colonoscopy procedures.
Supplemental oxygen (3 L/min) is given through nasal prong with capnography transducer in all patients.
Two min before the colonoscopy procedure, a bolus midazolam of 0.03 mg/kg with a bolus meperidine of 1.0 mg/kg are given intravenously over 60 sec in Group 1 or those of comparable amount of diluted remifentanil 0.4 mcg/kg are given in Group 2 at the colonoscopy room, and a continuous infusion of diluted remifentanil of 0.04 mcg/kg/min is followed in Group 2 or that of comparable amount of normal saline (placebo) is followed in Group 1.
The patients are asked to rate the degree of pain and distress (reverse satisfaction) by a 100 mm Visual analogue scale (VAS; 0 = minimum, 100 = maximum) just after passing the scope, during the scope, just after the completion of the colonoscopy and at the discharge from the recovery unit.
After colonoscopy, the patients are transferred to the recovery unit and evaluated every 5 min until ready for discharge from the 30 min stay in the recovery unit.
The patients are considered recovered if when they achieved an Aldrete score of 10 (Aldrete JA , Kroulik D . A postanesthetic recovery score. Anesth Analg 1970; 49: 924 - 34), have stable vital signs, are able to tolerate oral fluids, have no nausea, vomiting, or itching, and can walk unaided.
Assessment of readiness to ambulate is made by a blinded observer who remained with the patient for the duration of recovery unit stay.
The observer is instructed that the patients are required to walk as if they were leaving the recovery unit unescorted.
Aldrete score, patient pain and satisfaction (distress score) were determined every 5 min during colonoscopy and after colonoscopy up to 30 min. Time for achieving Aldrete score 10, patient's degree of pain, patient's satisfaction during and after colonoscopy, patient's ability to recall the explanations and instructions given during and before colonoscopy are determined and compared.
Aldrete score Respiration: Able to take deep breath and cough = 2, Dyspnea/shallow breathing = 1, Apnea = 0 O2 saturation: Maintains > 92% on room air =2, Needs O2 inhalation to maintain O2 saturation > 90% =1 , O2 saturation < 90% even with supplemental oxygen =0 Consciousness: Fully awake= 2, Arousable on calling = 1, Not responding = 0 Circulation: BP +/- 20 mm Hg preop =2, BP +/- 20-50 mm Hg preop =1, BP +/- 50 mm Hg preop =0 Activity: Able to move 4 extremities = 2, Able to move 2 extremities = 1, Able to move 0 extremities = 0
- Conditions
- Diagnostic Colonoscopy Screening
- Being tested
- Remifentanil, Midazolam, Meperidine, placebo (for remifentanil), placebo (for midazolam)
- Keywords
- colonoscopy, remifentanil, midazolam, meperidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
Also called Ultiva
continuous infusion 0.4 mcg/kg/min
MidazolamDrug
Also called dormicum
bolus injection
MeperidineDrug
Also called Pethidine Injection
bolus injection for 30 sec 1.0 mg/kg
placebo (for remifentanil)Drug
Also called normal saline
normal saline mimic diluted remifentanil
placebo (for midazolam)Drug
Also called normal saline
normal saline mimic to midazolam injection
placebo (for meperidine)Drug
Also called normal saline
normal saline mimic meperidine injection
| Study group | Role | What they receive |
|---|---|---|
| Remifentanil | Experimental | remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine) Receives: Drug: Remifentanil; Drug: placebo (for midazolam); Drug: placebo (for meperidine) |
| midazolam and meperidine | Active comparator | a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil) Receives: Drug: Midazolam; Drug: Meperidine; Drug: placebo (for remifentanil) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Recovery Time
Time from completing the colonoscopy to achieving Aldrete score 10 in the recovery unit
Aldrete score
- Respiration: Able to take deep breath and cough = 2, Dyspnea/shallow breathing = 1, Apnea = 0
- O2 saturation: Maintains > 92% on room air =2, Needs O2 inhalation to maintain O2 saturation > 90% =1 , O2 saturation < 90% even with supplemental oxygen =0
- Consciousness: Fully awake= 2, Arousable on calling = 1, Not responding = 0
- Circulation: BP +/- 20 mm Hg preop =2, BP +/- 20-50 mm Hg preop =1, BP +/- 50 mm Hg preop =0
- Activity: Able to move 4 extremities = 2, Able to move 2 extremities = 1, Able to move 0 extremities = 0
To estimate the required sample size, we conducted a pilot study to measure the recovery of 10 patients in each of groups-MM and -R before the present study. The means and standard deviations were 22.5 ± 9.5 and 7.5 ± 9.2 min respectively. We wished to be able to distinguish a difference of 7.5 min, thus half of the observed difference.
Measured: every 5 minutes after completing colonoscopy up to 30 min
Secondary outcomes (5)
Participants Assumed to Feel Frequent Pain
patients sound "Ah" at feeling pain during colonosocpy: if a patients sounds "Ah" > 6 times, the patient was assumed to feel frequent pain.
Measured: during and after colonoscopy
Bispectra Lindex Score
Bispectral index (BIS) score 0-100 maximal sedation=0, maximal sedation=100
Measured: every 5 min during and after colonoscopy
Patient's Distress Score
patients' distress in visual analogue scale 100 mm minimal distress=0, maximal distress=100
Measured: 5 min after the end of colonoscopy
Endoscopist Satisfaction
endoscopist's satisfaction after colonoscopy in visual analogue scale 100 mm
Measured: 5 min after the colonoscopy
Indigence of Patient's Recall
The numbers of patients who recalled instructions and explanations given during colonoscopy
Measured: after colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2012 (estimated)
- Study startDec 2012
- Primary completionFeb 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diagnostic Colonoscopy ScreeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Tae-Yop Kim, MD PhD, Konkuk University Medical Center
- Investigators
- Tae-Yop Kim, MD, PhD, Principal investigator, Konkuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01693185
- Sponsor's protocol ID
- KUH1160048
- Acronym
- remifentanil
- Status last verified
- May 2014
- First submitted
- 17 Sep 2012
- Last updated
- 18 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remifentanil Only vs. Combination Group Midazolam + Meperidine During Elective Colonoscopy
- ClinicalTrials.gov ID
- NCT01693185
- Acronym / sponsor ID
- remifentanil / KUH1160048
- Conditions
- Diagnostic Colonoscopy Screening
- Keywords
- colonoscopy, remifentanil, midazolam, meperidine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Dec 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 26 Sep 2012 (estimated)
- Results
- Posted 18 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the present study is to compare patient's recovery times after elective colonoscopy employing remifentanil only vs conventional combination of midazolam and meperidine
Detailed description
A regimen with combined administration of midazolam and meperidine has been widely used and provides quite satisfactory sedation as well as analgesia during colonoscopy. However, the relatively long duration of midazolam and meperidine often prolongs the recovery time after colonoscopy and delays discharge time. (Reimann FM , Samson U , Derad I et al. Synergistic sedation with low-dose midazolam and propofol for colonoscopies . Endoscopy 2000 ; 32 : 239 - 44).
Remifentanil, an ultra-short-acting opioid, provides excellent pain control during colonoscopy and its rapid onset and offset times are advantages over other conventional opioids including meperidine, in avoiding prolonged discharge time after the colonoscopy.
A total 54 patients, aged 18-65 years in American Society of Anesthesiologists physical status (ASA PS)1 and 2, scheduled for elective colonoscopy under Monitored Anesthesia Care in a University Hospital, will be recruited after obtaining written informed consent during the patients' first visit to outpatient/inpatient clinic for interview.
Predetermined patient identification numbers (PIN) and enrolment order were placed in sealed envelopes, and all patients were randomly assigned, at recruitment, to the midazolam-meperidine combination (group-MM) or remifentanil alone (group-R). If a patient was excluded during the study, the following patient assumed the status of the excluded patient.
Patients are allocated into one of two groups, Group 1 and Group 2 (27 patients each) according to the PIN at the recruitment.
The exclusion criteria were as follows: refusal or inability to provide written informed consent, age <19 years, pregnancy, previous history of large bowel surgery, a psychiatric disorder, an addictions to opiates or sedatives, a previous history of adverse events to any drug used in the present study, and performance of any additional diagnostic procedure after completion of colonoscopy.
All colonoscopic procedure is going to be performed by one Gastroenterologist (endoscopist).
On arriving in the endoscopy room, supplemental oxygen (2 L/min) was given through the mouth and both nostrils via a specially designed nasal prong which could monitor the end-tidal CO2 (ETCO2) level.
Before drug administration, the basal values of mean blood pressure (MBP), heart rate (HR), peripheral O2 saturation (SpO2), respiratory rate (RR), end-expiratory CO2 level (ETCO2), and the bispectral index (BIS), were recorded by a single observer, who also monitored these values every 5 min during entire colonoscopy procedures.
Supplemental oxygen (3 L/min) is given through nasal prong with capnography transducer in all patients.
Two min before the colonoscopy procedure, a bolus midazolam of 0.03 mg/kg with a bolus meperidine of 1.0 mg/kg are given intravenously over 60 sec in Group 1 or those of comparable amount of diluted remifentanil 0.4 mcg/kg are given in Group 2 at the colonoscopy room, and a continuous infusion of diluted remifentanil of 0.04 mcg/kg/min is followed in Group 2 or that of comparable amount of normal saline (placebo) is followed in Group 1.
The patients are asked to rate the degree of pain and distress (reverse satisfaction) by a 100 mm Visual analogue scale (VAS; 0 = minimum, 100 = maximum) just after passing the scope, during the scope, just after the completion of the colonoscopy and at the discharge from the recovery unit.
After colonoscopy, the patients are transferred to the recovery unit and evaluated every 5 min until ready for discharge from the 30 min stay in the recovery unit.
The patients are considered recovered if when they achieved an Aldrete score of 10 (Aldrete JA , Kroulik D . A postanesthetic recovery score. Anesth Analg 1970; 49: 924 - 34), have stable vital signs, are able to tolerate oral fluids, have no nausea, vomiting, or itching, and can walk unaided.
Assessment of readiness to ambulate is made by a blinded observer who remained with the patient for the duration of recovery unit stay.
The observer is instructed that the patients are required to walk as if they were leaving the recovery unit unescorted.
Aldrete score, patient pain and satisfaction (distress score) were determined every 5 min during colonoscopy and after colonoscopy up to 30 min. Time for achieving Aldrete score 10, patient's degree of pain, patient's satisfaction during and after colonoscopy, patient's ability to recall the explanations and instructions given during and before colonoscopy are determined and compared.
Aldrete score Respiration: Able to take deep breath and cough = 2, Dyspnea/shallow breathing = 1, Apnea = 0 O2 saturation: Maintains > 92% on room air =2, Needs O2 inhalation to maintain O2 saturation > 90% =1 , O2 saturation < 90% even with supplemental oxygen =0 Consciousness: Fully awake= 2, Arousable on calling = 1, Not responding = 0 Circulation: BP +/- 20 mm Hg preop =2, BP +/- 20-50 mm Hg preop =1, BP +/- 50 mm Hg preop =0 Activity: Able to move 4 extremities = 2, Able to move 2 extremities = 1, Able to move 0 extremities = 0
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remifentanil | Experimental | Drug: Remifentanil, Drug: placebo (for midazolam), Drug: placebo (for meperidine)remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine) |
| midazolam and meperidine | Active comparator | Drug: Midazolam, Drug: Meperidine, Drug: placebo (for remifentanil)a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil) |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 19-65 years
- American Society of Anesthesiologists physical status (ASA PS) 1-2
- Patients scheduled for elective colonoscopy under Monitored Anesthesia Care in a University Hospital
- Patients who signed on written informed consent.
Key exclusion criteria (6 listed)
- The exclusion criteria are refusal or inability to provide written informed consent
- Age < 18 years
- Pregnancy
- Previous large bowel surgery
- Psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RemifentanilAlso: Ultivacontinuous infusion 0.4 mcg/kg/min | Drug | Remifentanil |
| MidazolamAlso: dormicumbolus injection | Drug | midazolam and meperidine |
| MeperidineAlso: Pethidine Injectionbolus injection for 30 sec 1.0 mg/kg | Drug | midazolam and meperidine |
| placebo (for remifentanil)Also: normal salinenormal saline mimic diluted remifentanil | Drug | midazolam and meperidine |
| placebo (for midazolam)Also: normal salinenormal saline mimic to midazolam injection | Drug | Remifentanil |
| placebo (for meperidine)Also: normal salinenormal saline mimic meperidine injection | Drug | Remifentanil |
Primary outcome
The Recovery Time
Time frame: every 5 minutes after completing colonoscopy up to 30 min
Time from completing the colonoscopy to achieving Aldrete score 10 in the recovery unit Aldrete score * Respiration: Able to take deep breath and cough = 2, Dyspnea/shallow breathing = 1, Apnea = 0 * O2 saturation: Maintains > 92% on room air =2, Needs O2 inhalation to maintain O2 saturation > 90% =1 , O2 saturation < 90% even with supplemental oxygen =0 * Consciousness: Fully awake= 2, Arousable on calling = 1, Not responding = 0 * Circulation: BP +/- 20 mm Hg preop =2, BP +/- 20-50 mm Hg preop =1, BP +/- 50 mm Hg preop =0 * Activity: Able to move 4 extremities = 2, Able to move 2 extremities = 1, Able to move 0 extremities = 0 To estimate the required sample size, we conducted a pilot study to measure the recovery of 10 patients in each of groups-MM and -R before the present study. The means and standard deviations were 22.5 ± 9.5 and 7.5 ± 9.2 min respectively. We wished to be able to distinguish a difference of 7.5 min, thus half of the observed difference.
5 secondary outcomes
Participants Assumed to Feel Frequent Pain
Time frame: during and after colonoscopy
Bispectra Lindex Score
Time frame: every 5 min during and after colonoscopy
Patient's Distress Score
Time frame: 5 min after the end of colonoscopy
Endoscopist Satisfaction
Time frame: 5 min after the colonoscopy
Indigence of Patient's Recall
Time frame: after colonoscopy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tae-Yop Kim, MD, PhD principal investigator
Konkuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Remifentanil, Midazolam and Meperidine in people with Diagnostic Colonoscopy Screening, run by Konkuk University Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Recovery Time (time frame: every 5 minutes after completing colonoscopy up to 30 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2014.