| CTRI Number |
CTRI/2015/08/006130 [Registered on: 21/08/2015] Trial Registered Prospectively |
| Last Modified On: |
20/08/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Trial to evaluate the analgesic effect of dexmedetomidine infusion in robotic onco surgeries. |
|
Scientific Title of Study
|
Randomised controlled trial to evaluate the peri-operative analgesic effect of intra-operative dexmedetomidine infusion in robotic assisted laparoscopic onco- surgeries. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sumitra G Bakshi |
| Designation |
Professor |
| Affiliation |
Department of Anesthesia, Critical Care and Pain |
| Address |
Tata Memorial Hospital,
Mumbai. India.
Mumbai
MAHARASHTRA
4000012
India |
| Phone |
91-22-4177058 |
| Fax |
|
| Email |
sumitrabakshi@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumitra G Bakshi |
| Designation |
Professor |
| Affiliation |
Department of Anesthesia, Critical Care and Pain |
| Address |
Tata Memorial Hospital,
Mumbai. India.
Mumbai
MAHARASHTRA
4000012
India |
| Phone |
91-22-4177058 |
| Fax |
|
| Email |
sumitrabakshi@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumitra G Bakshi |
| Designation |
Professor |
| Affiliation |
Department of Anesthesia, Critical Care and Pain |
| Address |
Tata Memorial Hospital,
Mumbai. India.
Mumbai
MAHARASHTRA
4000012
India |
| Phone |
91-22-4177058 |
| Fax |
|
| Email |
sumitrabakshi@yahoo.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Dr E Borges Road,
Parel Mumbai - 12 |
| 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 Sumitra G Bakshi |
Tata Memorial Hospital |
Dr E. Borges Road
Parel Mumbai
Mumbai
MAHARASHTRA |
91-22-24309683
sumitrabakshi@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-I, Tata Memorial Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
All patients planned for robotic onco surgeries |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine as an infusion |
Dexmedetomidine infusion will be assessed for hemodynamic stability and fentanyl reducing property with respect to placebo ( saline) |
| Comparator Agent |
Dexmedetomidine infusion |
as an infusion intra-operative period to study its impact on hemodynamics, analgesia and anesthetic requirement. |
| Comparator Agent |
Saline |
used as placebo |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
ASA I-II patients posted for robot assisted laparoscopic surgery. |
|
| ExclusionCriteria |
| Details |
• Contraindication to the use of dexmedetomidine- c/o liver dysfunction- cirrhotic or pt with deranged LFT- e.g. Alanine transaminase（ALT）and (or) Aspartate aminotransferase（AST） level is more than twice the upper limit of normal, INR >1.5
• Patient with severe renal dysfunction, GFR less than 50 ml /hr
• All hypertensives,
• Patients with heart blocks or bradycardia HR <60,
• Patient with premature ventricular ectopics >5/min.
• Mini laparotomy( more than 5 cm ) planned for removal for anastomosis or surgical dissection e.g, robotic assisted cystectomy, whipples surgery, abdominal perineal resection.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Reduction in intraoperative opioids requirement by using dexmedetomidine iv infusion verses saline in robotic assisted laproscopic onco surgeries.
• Time to need for first rescue analgesic in postoperative period (PS3/10. At rest/ 4/10 at movement)
|
• Reduction in intraoperative opioids requirement by using dexmedetomidine iv infusion verses saline in robotic assisted laproscopic onco surgeries.
• Time to need for first rescue analgesic in postoperative period (PS3/10. At rest/ 4/10 at movement)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
· To compare intra-operative hemodynamics 5, 10, 20 ,and every 30 min till stop of infusion
· To compare no of episodes of hypotension / bradycardia
· Recovery time-time to eye opening after switching off of inhalational agents (i.e. inspiratory inhalational agent- zero )
· Incidence of Postoperative nausea and vomiting in either group |
Intraoperative and first 24 hours |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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 4 |
|
Date of First Enrollment (India)
|
31/08/2015 |
| 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="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Robotic assisted surgery has become widespread in a variety of operations. Intra-operative management of these cases is challenging to the anesthesiologists. Pneumoperitoneum and carbon dioxide insufflations lead to sympathetic response. Dexmedetomidine ( dexem) due to its distinct properties can be used as adjuvant analgesic in the form of intravenous infusion. We plan to study the use of dexem in robotic surgeries and evaluate its effect in hemodynamcis, analgesics, and anesthetic requirement. 46 ASA I-II patients planned to undergo robotic oncosurgeries will be included. After induction of general anesthesia, an independent group will randomize patient as per computer generated sheets and prepare study drug and handover the drug to the investigator. The study drug infusion will be started five minutes after insufflation of the abdomen.The initial bolus of dexem 1ug/kg and maintenance of 0.2 ug/kg/hr will be based on standard preparation of drug 2ug/ml. In the saline group equivalent amount of saline will be infused at that rate. The infusion will be stopped at the release of pnuemoperitonuem. All port sites will be infiltrated with local anesthetics.time to eye opening will be noted after reversal as per standard protocol. In the Post anesthetia care unit, patient will be reassessed after an hour for pain scores . At any point of time if pain at rest is more than 3 or at movement more than 4 - rescue analgesic will be administered as per protocol and time noted. |