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CTRI Number  CTRI/2021/05/033549 [Registered on: 11/05/2021] Trial Registered Prospectively
Last Modified On: 05/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing the benefits of 2 medicines (dexmedetomidine versus ketamine- dexmedetomidine combination) on spinal block in extending the duration of pain relief, reduction in surgical stress and early discharge from recovery room to ward in patients undergoing orthopedic surgery. 
Scientific Title of Study   Comparison of effects of intravenous infusion of dexmedetomidine versus low dose ketamine- dexmedetomidine combination on spinal block, surgical stress response and discharge readiness from pacu in orthopedic patients- a prospective, randomized controlled clinical trial.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Annapureddy Sai Krishna Reddy 
Designation  1st year PG student Anaesthesia 
Affiliation  Hamdard Institute of Medical Sciences and Research 
Address  Anaesthesia Department Hamdard Institute of Medical Sciences and Research Hamdard Nagar
Hamdard nagar, Block D, New Delhi, 110062
South
DELHI
110062
India 
Phone  7780513341  
Fax    
Email  saikrishnaannapureddy@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jyotsna Agarwal 
Designation  Associate Professor 
Affiliation  Hamdard Institute of Medical Sciences and Research 
Address  Anaesthesia Department Hamdard Institute of Medical Sciences and Research Hamdard Nagar
Hamdard nagar, Block D, New Delhi, 110062
South
DELHI
110062
India 
Phone  7780513341  
Fax    
Email  jyotsna.doctor@gmail.com  
 
Details of Contact Person
Public Query  
Name  Annapureddy Sai Krishna Reddy 
Designation  1st year PG student Anaesthesia 
Affiliation  Hamdard Institute of Medical Sciences and Research 
Address  Anaesthesia Department Hamdard Institute of Medical Sciences and Research Hamdard Nagar
Hamdard nagar, Block D, New Delhi, 110062
South
DELHI
110062
India 
Phone  7780513341  
Fax    
Email  saikrishnaannapureddy@gmail.com  
 
Source of Monetary or Material Support  
Hamdard Institute of Medical Sciences and Research, New Delhi 110062 
 
Primary Sponsor  
Name  Annapureddy Sai Krishna Reddy 
Address  Department of Anaesthesia,Hamdard Institute of Medical Sciences and Research, Hamdard Nagar, Delhi 110062 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Annapureddy Sai Krishna Reddy  Hamdard Institute of Medical Sciences and Research, New delhi 110062  Operation theatre, Block D HAHC hospital HIMSR Hamdard nagar Delhi 110062
South
DELHI 		 7780513341

saikrishnaannapureddy@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethics Committee, Hamdard Institute of Medical Sciences and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S729||Unspecified fracture of femur, (2) ICD-10 Condition: S821||Fracture of upper end of tibia, (3) ICD-10 Condition: S822||Fracture of shaft of tibia, (4) ICD-10 Condition: S823||Fracture of lower end of tibia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group A- Dexmedetomidine infusion  Loading dose- 0.5mcg/kg over 10 min Maintenance dose- 0.5mcg/kg/hr which will be titrated by 0.1mcg/kg/hr every 30 min to achieve a Ramsay Sedation score of 3-4  
Intervention  Group B-Low dose Ketamine and Dexmedetomidine infusion   Group B Bolus- Dexmedetomidine 0.5mcg/kg over 10 min and Ketamine 0.2mg/kg over 2-3 min Maintenanace- ketamine 0.2mg/kg/hr and Dexmedetomidine 0.5mcg/kg/hr which will be titrated by 0.1mcg/kg/hr every 30 min to maintain a RSS of 3-4  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  All patients of age 18-65 years, BMI 18-30 having an ASA physical status of either 1 or 2, posted for elective orthopedic lower limb surgeries under spinal anaesthesia will be included in this study  
 
ExclusionCriteria 
Details  1.Patients with prior addiction or analgesic abuse (opioid and non-steroidal anti-inflammatory drug medications).
2.Patients with a history of psychiatric or neurological disease, deafness.
3.Patients who do not achieve a sensory level of T10 or above.
4.Patients who do not achieve Modified Bromage scale of 1-2.
5.Patients complaining of pain within 60 minutes of the start of surgery.
6.Patients with difficult spinal requiring more than 3 attempts.
7.Surgeries having a duration of less than 1.5 hours and more than 4 hours.
8.Patients requiring supplementation with general anaesthetic agents.
 
 
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 
To compare the time of regression of sensory blockade to S1 between the two groups  Every 30 minutes postoperative till regression to S1 is achieved 
 
Secondary Outcome  
Outcome  TimePoints 
1.To compare the intraoperative hemodynamic stability between the two groups.
2.To compare the change in perioperative stress markers in preoperative and postoperative period between the two groups.
3.To compare the readiness of discharge from the PACU between the two groups. 		 1. Every 5 minutes intraoperatively.
2. At 6 hours and 24 hours
from end of surgery.
3. Every 5 minutes postoperative in PACU till modified Aldrete score 9 or more is achieved with sensory level of T10. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   21/05/2021 
Date of Study Completion (India) 11/10/2022 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary    We will be comparing the effects of intravenous infusion of Dexmedetomidine versus low dose Ketamine & Dexmedetomidine infusion on spinal block in lower limb orthopedic surgeries titrating the dose of Dexmedetomidine to maintain a Ramsay sedation score of 3-4. Patients will be selected based on the inclusion and exclusion criteria as mentioned above. Statistical analysis will be performed by using SPSS statistical software version 22.0 and R.3.2.0 and results will be tabulated in a Microsoft Office Excel worksheet. T-test will be used for comparing the parameters between the groups. This study helps in identifying whether low dose ketamine-dexmedetomidine combination is superior to dexmedetomidine alone in managing postoperative analgesia and hemodynamic stability in orthopedic surgeries under spinal anaesthesia. There are no studies on intravenous ketamine-dexmedetomidine combination in patients under spinal anaesthesia. If proven effective, the combination of dexmedetomidine-ketamine can be very useful in reducing patient length of stay in PACU and reduce hospital costs. 
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