| CTRI Number |
CTRI/2024/08/072344 [Registered on: 12/08/2024] Trial Registered Prospectively |
| Last Modified On: |
11/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
In this study 2 drugs are used to compare their effects on patients vitals during the surgery, the amount of anaesthesia drugs needed and how is the pain after the surgery in patients undergoing elective thoracic and lumbar spine surgeries. |
|
Scientific Title of Study
|
Effect of low dose ketamine with dexmedetomidine vs fentanyl on anesthetic requirements, intraoperative hemodynamics and recovery profile in patients undergoing elective thoracic and lumbar spine surgeries. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr H S Murthy |
| Designation |
Head of department of Anesthesia |
| Affiliation |
Manipal Hospitals |
| Address |
Department of Anaesthesia
2nd floor
Manipal Hospital
Old airport road, Rustom bagh,
Bangalore,
Karnataka
Bangalore
KARNATAKA
560017
India |
| Phone |
9945469997 |
| Fax |
|
| Email |
drhsmurthy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Archana K Raichurkar |
| Designation |
Consultant Anesthesiology |
| Affiliation |
Manipal hospital |
| Address |
Department of Anaesthesia
2nd floor
Manipal Hospital
Old airport road, rustom bagh
Bangalore Karnataka
Bangalore
KARNATAKA
560017
India |
| Phone |
9980362958 |
| Fax |
|
| Email |
archana.raichurkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Archana K Raichurkar |
| Designation |
Consultant Anesthesiology |
| Affiliation |
Manipal hospital |
| Address |
Department of Anaesthesia
2nd floor
Manipal Hospital
Old airport road, rustom bagh
Bangalore Karnataka
Bangalore
KARNATAKA
560017
India |
| Phone |
9980362958 |
| Fax |
|
| Email |
archana.raichurkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manipal hospitals , Old Airport Road, Rustom bagh,
Bengaluru
Karnataka, India
560017 |
|
|
Primary Sponsor
|
| Name |
Jagarapu kusuma |
| Address |
Manipal hospital
Od airport road, rustom bagh
Bangalore
Karnataka |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Kusuma Jagarapu |
Manipal hospitals |
Department of Anaesthesia
2nd floor
Manipal hospital, old airport road
Rustom bagh, Bangalore
Bangalore
KARNATAKA |
7702800968
kusumajagarapu1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fentanyl |
Iv fentanyl infusion at a rate of 1mcg/kg/hr is administered from induction untill beginning of skin closure. |
| Intervention |
Ketamine,dexmeditomidine |
The drugs are given IV infusion at dose of 0.25 mg/kg/hr of ketamine and 0.25mcg/kg/hr of dexmedetomidine throughout the surgery from induction untill skin closure begins. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age group 18 to 70 years
ASA status 1 or 2
Patients undergoing elective thoracic/ lumbar spine surgery under general anaesthesia. |
|
| ExclusionCriteria |
| Details |
Age group below 17 and above 70 years 2.ASA status III and above
3. Pregnancy
4. Patients for emergency surgical procedures
5. Patients with uncontrolled hypertension or uncontrolled Diabetes mellitus
6. Patients with cardiac dysfunction such as ischemic heart disease, heart blocks, valvular disease and heart failure
7 Patients with severe respiratory disease such as asthma or chronic obstructive pulmonary disease.
8. Patients with severe hepatic, renal or endocrine disease
9. Patients who have undergone prior spine surgeries
10. Patients with history of drug abuse
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To access the effect of low dose Ketodex infusion on intraoperative analgesic and anaesthetic requirements(amount of anesthetic and analgesics used) |
Intra operative , post induction to extubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To access the effect of low dose Ketodex infusion on intraoperative hemodynamic profile, blood loss during the surgery and emergence from anaesthesia. |
Intra operative , post induction to extubation. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
25/08/2024 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Spinal surgeries involve hemodynamic alterations, blood loss, anaesthetic and analgesic requirements. With the use of increasing doses of opioids in the intraoperative period, there have been incidents of central sensitization, allodynia and post operative nausea and vomiting.
Dexmedetomidine has been widely used as an anaesthetic adjuvant for its opioid sparing effects. It decreases sympathetic tone, reduces heart rate and has the propensity to develop hypotension.
Ketamine has also been used as an anaesthetic adjuvant in low doses for its opioid sparing effects3 and reduced post operative nausea and vomiting. Ketamine stimulates the cardio-respiratory system and can have psychomimetic adverse effects.
A combination of dexmedetomidine and ketamine has low incidence of adverse effects, good analgesic, predictable recovery and no cardiorespiratory depression and reduce opioid usage.
The primary aim of our study will be, to compare its effect on intraoperative analgesic and anaesthetic requirements. The secondary aim will be, to compare intraoperative hemodynamic profile, blood loss during the surgery and emergence from anaesthesia.
|