| CTRI Number |
CTRI/2014/08/004806 [Registered on: 01/08/2014] Trial Registered Retrospectively |
| Last Modified On: |
31/07/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between Dexmedetomidine and Fentanyl for pain relief after abdominal surgeries. |
|
Scientific Title of Study
|
COMPARISON OF ANALGESIC EFFICACY OF DEXMEDETOMIDINE VERSUS FENTANYL AS AN ADJUNCT TO THORACIC EPIDURAL WITH BUPIVACAINE IN PATIENTS UNDERGOING UPPER ABDOMINAL SURGERY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shweta Nandkumar Pokale |
| Designation |
Junior Resident |
| Affiliation |
Postgraduate Institute Of Medical Education And Research |
| Address |
Department of Anaesthesia,
PGIMER,
Sector 12
Sector 12,
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9814012468 |
| Fax |
|
| Email |
snp1986@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neerja Bharti |
| Designation |
Associate Professor |
| Affiliation |
Postgraduate Institute Of Medical Education And Research |
| Address |
Department of Anaesthesia,
PGIMER,
Sector 12
Sector 12,
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9914209527 |
| Fax |
|
| Email |
bhartineerja@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Shweta Nandkumar Pokale |
| Designation |
Junior Resident |
| Affiliation |
Postgraduate Institute Of Medical Education And Research |
| Address |
Department of Anaesthesia,
PGIMER,
Sector 12
Sector 12,
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9814012468 |
| Fax |
|
| Email |
snp1986@gmail.com |
|
|
Source of Monetary or Material Support
|
| PostGraduate institute of medical education and research Chandigarh |
|
|
Primary Sponsor
|
| Name |
PostGraduate institute of medical education and research |
| Address |
PostGraduate institute of medical education and research,sector 12, Chandigarh, chandigarh-160012 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shweta N Pokale |
department of anaesthesia |
post graduate institute of medical education and research,chandigarh-160012
Chandigarh
CHANDIGARH |
9814012468
snp1986@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Intramural Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
scheduled for hepaticojejunostomy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
dexmedetomidine |
50 mics with 10 ml of 0.125% bupivacaine in thoracic epidural,intraoperatively.post-operatively 1 mics/ml dexmedetomidine with 0.125% bupivacaine-3ml bolus via PCEA pump with 15 min lock-out interval |
| Comparator Agent |
Fentanyl |
50 mics with 10 ml of 0.125% bupivacaine in thoracic epidural intraoperatively.post-operatively 1 mics/ml fentanyl with 0.125% bupivacaine-3ml bolus via PCEA pump with 15 min lock-out interval |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA Class I and II, undergoing elective hepaticojejunostomy |
|
| ExclusionCriteria |
| Details |
• BMI>35 kg/sq metre
• Renal or hepatic dysfunction
• Known cardiovascular disorder
• Patients on beta-blockers, on long term treatment of antipsychotic drugs
• Known allergy or senstivity to dexmedetomidine, bupivacaine or fentanyl
• Contraindication to insertion of epidural catheter (local infection, spine deformities etc.)
• Alcohol abuse, heavy smoking
• Inability to use PCEA device
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| postoperative pain and analgesic requirements |
24 hours postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| intraoperative analgesia and hemodynamic parameters |
assessed every 5 min after start of epidural infusion for 30 min ,every 15 min till end of surgery. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
02/05/2013 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
the purpose of the study was to compare and quantify the analgesic efficacy of dexmedetomoidine and fentanyl when both were used as an adjunct to thoracic epidural in patients undergoing hepaticojejunostomy under general anaesthesia. the addition of dexmededtomidine to 0.125% bupivacaine intraoperatively and postoperatively significantly reduces the requirement of bupivacaine as compared to fentanyl with comparable hemodynamic stability. the total consumption of rescue analgesia was significantly lower in dexmedetomidine group as compared to fentanyl group. the postoperative pain scores were comparable throughout the study between two groups and patients in dexmedetomidine group were more sedated.The heart rate was significantly lower in dexmedetomidine group as compared to fentanyl though the other haemodynamic parameters were comparable throughout the study.two patients in fentanyl group developed PONV whereas 2 patients in dexmed group developed mild nausea.no other side effects were reported in either of the two groups. |