| CTRI Number |
CTRI/2018/10/016016 [Registered on: 15/10/2018] Trial Registered Prospectively |
| Last Modified On: |
23/08/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparison of Intrathecal Dexmedetomidine and Fentanyl on Vital parameters, stress response and Post-operative pain in Laparoscopic cholecystecomy surgeries. |
|
Scientific Title of Study
|
Comparative evaluation of Intrathecal Dexmedetomidine and Fentanyl for Hemodynamic stress response and Post-operative Analgesia in Laparoscopic Cholecystectomy. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ProfJNirmala |
| Designation |
Professor in Anesthesiology |
| Affiliation |
Nizams Institute Of Medical Sciences, Hyderabad |
| Address |
Deapartment of Anesthesiology,
Old Block,1stfloor,
Nizams Institute Of Medical Sciences, Panjagutta,Hyderabad.
Hyderabad
ANDHRA PRADESH
500082
India |
| Phone |
9849422749 |
| Fax |
|
| Email |
njonnavithula@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ProfJNirmala |
| Designation |
Professor in Anesthesiology |
| Affiliation |
Nizams Institute Of Medical Sciences, Hyderabad |
| Address |
Department of Anesthesiology,
Old Block, 1 st floor,
Nizams Institute Of Medical Sciences, Panjagutta,Hyderabad.
Hyderabad
ANDHRA PRADESH
500082
India |
| Phone |
9849422749 |
| Fax |
|
| Email |
njonnavithula@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ProfJNirmala |
| Designation |
Professor in Anesthesiology |
| Affiliation |
Nizams Institute Of Medical Sciences, Hyderabad |
| Address |
Department of Anesthesiology,
Old Block, 1 st floor,
Nizams Institute Of Medical Sciences, Panjagutta,Hyderabad.
Hyderabad
ANDHRA PRADESH
500082
India |
| Phone |
9849422749 |
| Fax |
|
| Email |
njonnavithula@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nizams Institute of Medical Science,Panjagutta, Hyderabad, 500082 |
|
|
Primary Sponsor
|
| Name |
Nizams Institute of Medical Sciences |
| Address |
Panjagutta, Hyderabad, 500082 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Nizams Institute of Medical Sciences |
Panjagutta, Hyderabad |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| JNirmala |
Nizams Institute of Medical Sciences |
Operation Theatre complex, Specialty block,5th floor
Hyderabad
ANDHRA PRADESH |
9849422749
njonnavithula@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMS INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C260||Malignant neoplasm of intestinal tract, part unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
Patients in this group will be categorised as Group1, and 10mcg of the drug will be given Intrathecal route. Its effect will be studied on hemodynamic stress response during pneumo-peritoneum stage of surgery and post-operative analgesia up to 24 hours. |
| Intervention |
Fentanyl |
Patients included in this group will be categorised as Group2, and will be given 50mcg of the drug intrathecal route.Its effect will be studied on hemodynamic stress response during pneumo-peritoneum stage of surgery and post-operative analgesia up to 24 hours. |
| Comparator Agent |
Normal Saline |
Patients in this group will be categorised as Group3 and will be injected equal volume (1ml) of normal saline intrathecally.Its effect will be studied on hemodynamic stress response during pneumo-peritoneum stage of surgery and post-operative analgesia up to 24 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
A total of 75 patients of ASA GI and ASA GII divided in to three groups of 25 each in Group 1 ,2 and 3 and Intrathecal Dexmedetomidine 10mcg, Fentanyl 5omcg and equal volume of Normal saline used in three groups respectively. The response is noted in different stages of surgery like pneumo-peritoneum creation, deflation, recovery and post-operative analgesia. |
|
| ExclusionCriteria |
| Details |
Coagulation abnormality
Infection at the site of Injection
Emergency surgery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic stress response to pneumo-peritoneum |
At the end of surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Postoperative analgesia |
Upto 24 hours after end of surgery |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
15/10/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized double blind clinical investigation planned to evaluate effect of intrathecal Fentanyl and Dexmedetomidine on the hemodynamic stress response and postoperative analgesia when compared to a placebo control group.A total of 75 ASA Grade 1 and Grade 2 Patients will be enrolled after written informed consent and assigned to 25 to each group in a computerized randomly generated no.Baseline vitals noted in each of these patients. Intra-thecal Fentanyl 50mcg or Dexmedetomidine 10mcg or equal volume of sterile saline will be given under aseptic precaution in their respective allocated group. All the patients will be induced with Inj.Propofol 2mg/kg, Inj.Fentanyl 2mcg/kg and Inj.Atracurium 0.5mg/kg, and Sevoflurane after Pre-oxygenation for 3 minutes and Intubation to be done with adequate sized tube. All the patients will be given 30mg of Inj Ketorolac in 100 ml of NS slow Iv Infusion completed before incision.Anesthesia will be maintained with sevoflurane, ventilation with oxygen and air, intermittent use of Inj Atracurium. Sevoflurane will be titrated to maintain MAP around 20% of baseline, else short bolus of Inj Nitroglycine will be given IV. After Completion of surgery neuromuscular blockade reversal to be done with Inj Neostigmine 50mcg/kg, Inj Glycopyrrolate 10mcg/kg. Vitals In all phases of pneumoperitoneum will be noted. Recovery time from anesthesia will be noted by calculating time from stopping inhalation agents to extubation. VAS score calculated, any score more than 4 will be given with rescue analgesia with Inj Paracetamol 1mg/kg slow IV infusion. |