Remifentanil Only vs. Combination Group Midazolam + Meperidine During Elective Colonoscopy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The Recovery Time
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Remifentanil
remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine)
干预措施: Remifentanil (Drug)
Remifentanil
remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine)
干预措施: placebo (for midazolam) (Drug)
Remifentanil
remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine)
干预措施: placebo (for meperidine) (Drug)
midazolam and meperidine
a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil)
干预措施: Midazolam (Drug)
midazolam and meperidine
a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil)
干预措施: Meperidine (Drug)
midazolam and meperidine
a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil)
干预措施: placebo (for remifentanil) (Drug)
结局指标
主要结局
The Recovery Time
时间窗: 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.
次要结局
- Participants Assumed to Feel Frequent Pain(during and after colonoscopy)
- Bispectra Lindex Score(every 5 min during and after colonoscopy)
- Patient's Distress Score(5 min after the end of colonoscopy)
- Endoscopist Satisfaction(5 min after the colonoscopy)
- Indigence of Patient's Recall(after colonoscopy)
研究者
Tae-Yop Kim, MD PhD
Professor of Anesthesiology
Konkuk University Medical Center