| CTRI Number |
CTRI/2020/04/024816 [Registered on: 23/04/2020] Trial Registered Prospectively |
| Last Modified On: |
15/04/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two medicines namely Inj Dexmedetomidine and Inj Dexamethasone for vomiting prevention in patients undergoing back bone surgeries.(To find which among the two medicines is better for the purpose of vomiting prevention after the surgery) |
|
Scientific Title of Study
|
Comparison of Dexmedetomidine and Dexamethasone as an adjuvant to ondansetron for prevention of postoperative nausea vomiting in patients undergoing elective spine surgery- A Randomised Double blind Clinical Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NA |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ramyavel Thangavelu |
| Designation |
Associate Professor |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
Room no 2, 2 nd floor ETC buiding, Department of Anaesthesiology,
Pondicherry Institute of Medical Sciences
Puducherry
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9487630425 |
| Fax |
|
| Email |
ramyavel1988@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramyavel Thangavelu |
| Designation |
Associate Professor |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
Room no 2, 2nd floor, ETC building, Department of Anaesthesiology, PIMS, Puducherry
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9487630425 |
| Fax |
|
| Email |
ramyavel1988@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramyavel Thangavelu |
| Designation |
Associate Professor |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
Room no 2, 2 nd floor ETC building, Department of Anaesthesiology,PIMS, Puducherry.
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9487630425 |
| Fax |
|
| Email |
ramyavel1988@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pondicherry Institute of Medical Sciences,
( A unit of Madras Medical Misssion)
Ganapathichettikulam, Village no 20, kalapet, Puducherry 605014 |
|
|
Primary Sponsor
|
| Name |
Dr Ramyavel Thangavelu |
| Address |
No 10 Jeevanantham Street, Ashok Nagar, Lawspet, Puducherry |
| Type of Sponsor |
Other [Principal Investigator] |
|
|
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 Ramyavel Thangavelu |
Pondicherry Institute of medical sciences |
Department of Anaesthesiology, Room no 3, second floor, ETC building, PIMS.
Pondicherry
PONDICHERRY |
9487630425
ramyavel1988@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIMS institute ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M464||Discitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Inj Dexamethasone |
Inj Dexamethasone in the dose 0.1 mg/kg bolus at the start of surgery. |
| Intervention |
Inj Dexmedetomidine |
Inj Dexmedetomidine as a continuous infusion at the rate of 0.2 mcg/kg/hr initiated at the start of surgery continued till skin closure. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All patients aged 18-70 years belonging to ASA 1 and 2 undergoing elective spine surgery under general anaesthesia.
|
|
| ExclusionCriteria |
| Details |
1) Any allergy/hypersensitivity to the study medication.
2) Patients with BMI > 30 kg/m2
3) Patients for emergency spine procedures.
4) Patients who received opioid, antiemetics or any steroid therapy 24 hrs prior to surgery.
5) Patients had episode of nausea, vomiting or retching in the 24 hrs prior to anaesthesia.
6) Patients with history of GERD
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Grade of Post operative nausea vomiting
(Grade 0: no nausea and no retching
Grade 1: complaining of sickness or retching
Grade 2: vomiting one or two times in 30 minutes
Grade 3: vomiting more than two times in 30 minutes
|
Grade of PONV will be recorded
at
0 hrs/Baseline (immediate post surgery)
4 hrs
8 hrs
12 hrs
16 hrs
20 hrs
24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Mean arterial pressure (MAP)and Heart rate (HR).
2.Dose of additional Inj fentanyl administered
3. Concentration of inhalational agent used.
4. Grade of Sedation postoperatively.
|
MAP, HR, Inj Fentanyl and Conc of Inhalational agent will be assessed at:
Baseline (at start of surgery) followed by every 30 min till the end of surgery.
Grade of sedation will be assessed at:
At baseline (immediately post surgery) followed by every 4 hrs till 24 hrs post surgery. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2020 |
| 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
|
NIL as of now. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The incidence of Post operative nausea vomiting (PONV) is especially high in high risk patients, one of them being patients undergoing spine surgery. Multimodal therapy with a combination of antiemetics like 5 HT3 antagonists combined with phenothiazines, antihistamines and steroids is the preferred modality for PONV prevention in high risk patients. Recently the effect of dexmedetomidine , an alpha 2 agonist, has been the focus of clinical researches. we aimed to evaluate the efficacy of dexmedetomidine when used as an adjuvant to ondansetron for PONV and compare it with dexamethasone ondansetron combination. After getting institutional ethical committee clearance, 100 patients of age group 18 to 70 years will be enrolled in the study. After standard induction,intubation and positioning the patient prone, the study group will receive either 5 ml saline bolus followed by Inj dexmedetomidine infusion continued throughout the period of surgery or Inj Dexamethasone 0.1 mg/kg as 5 ml bolus follwoed by saline infusion throughout the surgery. The anaesthetist blinded to the study will be recording the hemodynamics (HR, MAP) , total dose of opioid and inhalational agent received intraoperatively. After reversal and extubation, patients will be shifted to recovery and followed up every four hours for 24 hours for the presence of PONV and the total rescue antiemetic received.
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