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effects of ketamine-fentanyl combination and propofol- remifentanil combination for sedation during Endoscopic retrograde cholangiopancreatography

Assessment of the effects of ketamine-fentanyl combination versus propofol- remifentanil combination for sedation during Endoscopic retrograde cholangiopancreatography

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2014052317651N1
Enrollment
62
Registered
2014-06-12
Start date
2012-08-22
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Disorders of gallbladder, biliary tract and pancreas. Disorders of gallbladder, biliary tract and pancreas in diseases classified elsewhere

Interventions

Intervention 1: Ketamine group will receive a loading dose of Ketamine 0.5 mg/Kg body weight intravenously over 60 seconds and then Fentanyl 1 mcg/Kg body weight intravenously. According to sedation l
Treatment - Drugs
Ketamine group will receive a loading dose of Ketamine 0.5 mg/Kg body weight intravenously over 60 seconds and then Fentanyl 1 mcg/Kg body weight intravenously. According to sedation level, in Ramsay
Propofol group will receive Propofol l mg/Kg body weight intravenously over 60 seconds and then Remifentanil 0.05 mcg/Kg body weight/min intravenously. Intravenous infusion of propofol will be maintai

Sponsors

Isfahan university of medical sciences, faculty of medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
25 Years to 70 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Patient at age between 25 to 70 years; ASA physical status I and II; Patients without anatomic airway abnormalities; Patients without severe cardiovascular and respiratory disease; Patients without severe psychological problem; Patients who are not pregnant; Patients who are not smoker or addict; Patients without history of previous ERCP. Exclusion criteria: Occurring severe ERCP complications such as perforation and bleeding; ERCP procedural failure; Changing the sedation plan to the general anesthesia.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Sedation level. Timepoint: every 5 min during the first 15 min of the procedure and then every 15 min until the end of procedure. Method of measurement: Ramsay scale.

Secondary

MeasureTime frame
Dose repeats. Timepoint: during ERCP. Method of measurement: Questionnaire.;Recovery time. Timepoint: after procedure. Method of measurement: Aldrete score.;Systolic blood pressure. Timepoint: before the intervention then every 5 min during the first 15 min of the procedure and then every 15 min until the end of procedure and then at the entrance to the recovery room and after first 15 min. Method of measurement: sphygmomanomete.;Heart rate. Timepoint: before the intervention then every 5 min during the first 15 min of the procedure and then every 15 min until the end of procedure and then at the entrance to the recovery room and after first 15 min. Method of measurement: Beat/minute.;O2 saturation. Timepoint: before the intervention then every 5 min during the first 15 min of the procedure and then every 15 min until the end of procedure and then at the entrance to the recovery room and after first 15 min. Method of measurement: Pulse oximetry.;Respiratory rate. Timepoint: before the intervention then every 5 min during the first 15 min of the procedure and then every 15 min until the end of procedure and then at the entrance to the recovery room and after first 15 min. Method of measurement: per minute.;Retching. Timepoint: during ERCP. Method of measurement: Questionnaire.;Apnea occurrence. Timepoint: during ERCP. Method of measurement: Questionnaire.;Patient’s pain intensity. Timepoint: at 60 min post procedure. Method of measurement: Visual analogue scale(VAS).;Patient’s satisfaction. Timepoint: after procedure. Method of measurement: Visual analogue scale(VAS).;Intensity of nausea. Timepoint: at 60 min post procedure. Method of measurement: Visual analogue scale(VAS).;Endoscopist’s satisfaction. Timepoint: after procedure. Method of measurement: Visual analogue scale(VAS).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSayed Morteza Heidari - Anaesthesiologist

Alzahra Hospital

m_heidari@med.mui.ac.ir ; alzahra@mui.ac.ir+98 31 3668 5555

Outcome results

None listed

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