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Comparision of propofol and midazolam analgesia for gastrointestinal endoscopy

Safety and efficacy of low dose intravenous propofol in compare with midazolam during colonoscopy and ERCR in Shahroud's Imam Hossein hospital

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2013011612123N1
Enrollment
140
Registered
2013-03-16
Start date
2011-09-07
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

Condition 1: Analgesia for Endoscopic Retrograde Cholangiopancreatography. Condition 2: Analgesia for Endoscopic Retrograde Cholangiopancreatography. Condition 3: Analgesia for Endoscopic Retrograde Cholangiopancreatography. Condition 4: Analgeia for colonoscopy. Condition 5: Analgeia for colonoscopy. Condition 6: Analgeia for colonoscopy. Condition 7: Analgeia for colonoscopy. Condition 8: Analgeia for colonoscopy. Cholelithiasis Cholecystitis Obstruction of bile duct Malignant neoplasm of

Interventions

Intervention 1: In control group (group A) sedation will be induced with slow injection (in 20 sec.) of 0.1 mg/kg midazolam followed by Dextrose water 5% infusion with syring pump.Syringes will be co
Treatment - Drugs
In control group (group A) sedation will be induced with slow injection (in 20 sec.) of 0.1 mg/kg midazolam followed by Dextrose water 5% infusion with syring pump.Syringes will be covered by aluminu
In intervention group (group B) intravenous propofol with induction dose of 0.8 mg/kg followed by maintenance dose of 25 µg/kg/min through a syringe pomp.Syringes will be covered by aluminum foil.

Sponsors

Deputy of research, Shahroud University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 89 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: admitted patients for diagnostic and therapeutic colonoscopy or ERCP in gastroenterology clinic in Shahroud’s Imam Hossein hospital; 18 to 89 years old; anesthesia risk of 1, 2 or 3 (According to American society of anesthesiologist's classification). Exclusion criteria: patient refuse; under 18 and over 89 years old; anesthesia risk of 4 and 5 (According to American society of anesthesiologist's classification); a history of drug abuse; sensitivity to egg.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Systolic blood pressure. Timepoint: before procedure and every 5 minutes during operation. Method of measurement: By Novin saadat's automatic Non invasive BP monitoring and record as mmHg.;Heart rate. Timepoint: before procedure and every 5 minutes during operation. Method of measurement: By Novin saadat's cardiac monitoring and record as beat per minute.;Respiratory rate. Timepoint: before procedure and every 5 minutes during operation. Method of measurement: BY Novin saadat's Non invasive monitoring and record as beat per minute.;O2 Saturation. Timepoint: before procedure and every 5 minutes during operation. Method of measurement: By Novin saadat's Pulse oximetery and chart as percent.;Movement. Timepoint: throughout the operation. Method of measurement: Clinical observation and chart as Yes or No.;Phonation. Timepoint: throughout the operation. Method of measurement: Clinical observation and chart as Yes or No.;Recovery time. Timepoint: Every 5 minutes during recovery. Method of measurement: The end of recovery will be determined by Modified Alderet scoring system (MASS). In this system, scoring 9 points in 5 variables of Consciousness, circulation (systemic blood pressure), breathing, SPO2, and activity, each of 2 points, specifies the end of recovery.;Endoscopist satisfaction from patient's condition. Timepoint: End of operation. Method of measurement: a five point scale (1= poor, 2= weak, 3= average, 4= good and 5 = excellent).Questionarie, chart by gastroentrologist.;The time to home readiness. Timepoint: Every 5 minutes during recovery until home readiness. Method of measurement: The time required to achieve a state of home readiness will be determined by Post Anesthesia Discharge Scoring system (PADSS). This scoring system assigned a number of 0, 1, or 2 to five variables: vital signs (pulse rate and blood pressure), activity level, nausea and vomiting, pain and surgical bleeding. Patients achieving a score of at least 9 are acceptable for discharge. char

Secondary

MeasureTime frame
Postoperative nausea and vomiting. Timepoint: Throughout the recovery. Method of measurement: Clinical observation and chart as Yes or No.;Postoperative pain and agitation. Timepoint: After Procedure and every 5 minutes till discharge. Method of measurement: Questionarie and chart as Yes or No.;Awareness. Timepoint: End of recovery. Method of measurement: Questionnaire and record as Yes or No.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactJavad Nourian MD

Imam Hossein Hospital, Shahroud University of Medical Sciences, Shahroud, Iran

javadnourian@shmu.ac.ir , javadnourian@gmail.com+98 27 3334 2001

Outcome results

None listed

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