Effect of propofol-fentanyl, propofol-midazolam and propofol-dexmedetomidine combination on pulse rate, blood pressure and postoperative recovery for endoscopic procedure

Phase 4

Completed

Conditions: ASA grade I or III patient, Non diabetic, Non hypertensive and require Endoscopic retrograde cholangiopancreatography

Registration Number: CTRI/2015/06/005842

Lead Sponsor: Apollo Hospitals Bilaspur

Brief Summary: Endoscopic retrograde cholangiopancreatography (ERCP) is generally performed under conscious sedation. Current drugs include benzodiazepines with an opioid, with or without propofol. in recent years, dexmedetomidine has been used as an alternative to midazolam in conscious sedation. Hence the present study is designed to evaluate and compare the efficacy of propfol-midazolam, propofol-fentanyl and propofol-dexmedetomidine combination on hemodynamics and postoperative recovery in ERCP patients.

All selected patients will be randomized in to three groups (31 in each group)

Group I - Fentanyl 1mcg/kg over 2 min, followed by propofol loading dose 1-2 mg/kg before procedure over a period of 5 min and maintenance infusion at a rate of 1-3 mg/kg/hr throughout the procedure

Group II - Midazolam 0.04mg/kg over 2 min, followed by propofol loading dose 1-2 mg/kg before procedure over a period of 5 min and maintenance infusion at a rate of 1-3 mg/kg/hr throughout the prcedure

Group III - Dexmedetomidine 1mcg/kg over 10 min, followed by propofol loading dose 1-2 mg/kg before procedure over a period of 5 min and maintenance infusion at a rate of 1-3 mg/kg/hr throughout the procedure

The following parameters were recoreded-

1) Heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure and oxygen saturation at various intervals

2) Total dose of propofol

3) Postoperative recovery in between three groups

4) Ant complication

All data will be recorded and statistically analysed.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 93

Inclusion Criteria

ASA grade I and III.

Exclusion Criteria

1.Patients with known sensitivity to study drugs 2.History of drug or alcohol abuse, 3.Morbid obesity (body mass index>40), 4.History of chronic pain or daily intake of analgesics 5.Oral anticoagulant use (warfarin) 6.Patients with bleeding diathesis 7.Impaired kidney or endocrinal functions 8.Pregnant patients and 9.Psychiatric patients.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure and oxygen saturation (SpO2)	Basal, After study drug, After induction, at various time intervals during procedure, After procedure

Secondary Outcome Measures

Name	Time	Method
Total dose of propofol,Postoperative recovery in between two groups (modified Aldrete score) and any complication

Trial Locations

Locations (1): Apollo Hospitals Bilaspur
🇮🇳
Bilaspur, CHHATTISGARH, India
Apollo Hospitals Bilaspur
🇮🇳Bilaspur, CHHATTISGARH, India
Dr Vinit Kumar Srivastava
Principal investigator
09755557539
drvinit75@gmail.com