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CTRI Number  CTRI/2023/06/053997 [Registered on: 16/06/2023] Trial Registered Prospectively
Last Modified On: 12/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparison between two drugs as an alternative to drugs causing nausea ,vomiting ,sedation and respiratory depression in spine surgeries. 
Scientific Title of Study   Efficacy of intravenous dexmedetomidine vs lignocaine as adjuvant in opioid free anesthesia in lumbar spine surgeries :A randomized controlled trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Remya Santhosh 
Designation  1st year PG resident  
Affiliation  St Johns Medical College and Hospital 
Address  PG Resident Department of Anesthesiology St Johns medical college and hospital Bengaluru

Bangalore
KARNATAKA
560034
India 
Phone  9526034676  
Fax    
Email  remya1794@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Remya Santhosh 
Designation  1st year PG resident  
Affiliation  St Johns Medical College and Hospital 
Address  PG Resident Department of Anesthesiology St Johns medical college and hospital Bengaluru

Bangalore
KARNATAKA
560034
India 
Phone  9526034676  
Fax    
Email  remya1794@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr M Manjuladevi 
Designation  Professor 
Affiliation  St Johns Medical College and Hospital 
Address  Professor Department of Anesthesiology St Johns medical college and hospital Bangaluru

Bangalore
KARNATAKA
560034
India 
Phone  9449059395  
Fax    
Email  drmanjula95@yahoo.com  
 
Source of Monetary or Material Support  
St Johns Medical College and Hospital Sarjapur road Koramangala Bengaluru 560034 
 
Primary Sponsor  
Name  St Johns Medical College and Hospital 
Address  St Johns Medical College and Hospital Sarjapur Marathahalli road Beside Bank of Baroda John Nagar Koramangala Bengaluru Karnataka 560034 
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 
Remya Santhosh  St Johns Medical College and Hospital   Room no.9 2nd floor operation theatre complex Department of Anesthesia Sarjapur Road Koramangala Bengaluru 560034 Karnataka India
Bangalore
KARNATAKA 		 9526034676

remya1794@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M511||Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with radiculopathy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intraoperative use of dexmedetomidine  Patients in group D are given 1µg/kg Dexmedetomidine over 15 min followed by 0.5µg/kg/hour 
Comparator Agent  Intraoperative use of lignocaine  Patients in group Group -L are given 1.5mg/kg Lignocaine bolus over 15 min followed by 1 mg/kg/hour 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  All ASA I and II adult patients aged 18 years to 80 years posted for lumbar spine surgeries 
 
ExclusionCriteria 
Details  1.Pregnant and lactating women
2.Patients with intellectual disability ,dementia and alzheimer’s disease
3.Known history of hypersensitivity to local anesthetic agents
4.Coagulopathy
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess duration of analgesia between the two groups (Lignocaine vs Dexmedetomidine) in the postoperative period  Duration of analgesia:Time from stop of study drug to first request of analgesia 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the hemodynamic parameters such as heart rate, Systolic blood pressure(SBP), Diastolic blood pressure(DBP) and Mean arterial pressure (MAP) and Saturation (SpO2) intraoperatively between the two groups  Hemodynamic parameters -HR, Blood pressure (SBP, DBP and MAP), SpO2 is monitored every 15 min until end of surgery. 
To assess the total rescue analgesic (Ketamine) consumed between the two groups  Total rescue analgesic ( IV Ketamine) consumed at the end of surgery 
To assess total analgesic consumption of lignocaine and dexmedetomidine.  Total analgesic consumption of the study drugs.(lignocaine and dexmedetomidine) 
To compare side effects between the two drugs.  Side effects like PONV, sedation, respiratory depression (Respiratory rate8) and Desaturation (SpO294%) on arrival to PACU, 20min, discharge from PACU, 2hrs,4hrs, 8hrs,12hrs and 24 hrs 
To assess the total dose of rescue analgesia used postoperatively between the two groups  Total dose of IV PCA Fentanyl used at the end of 24 hrs 
To assess NRS score at rest & movement  PACU at 20 min, discharge from PACU 2hrs,4hrs,8hrs,12hrs & 24hrs 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   26/06/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   1.Ramanarayanan Ragupathy et al Opioid free anaesthesia for laproscopic surgeries -A prospective non-randomised study in a tertiary care hospital.Indian journal of Anaesthesia 2022;66:207-12 2.Martina Rekatsina et al Effect of intravenous Dexmedetomidine versus Lidocaine on post operative pain, analgesic consumption and functional recovery after abdominal gynecological surgery; A randomised placebo-controlled Double Blind study. Pain Physician 2021;24:E997-E1006 3.Vishwadeep Singh et al Comparing efficacy of intravenous Dexmedetomidine and Lidocaine on Perioperative Analgesic consumption in patients undergoing laproscopic surgery.Anaesthesia essays and researches 2022;16(3):353-9. 4.Ahmed M Salem et al Opioid free anaesthesia for laproscopic hysterectomy :Is it appropriate ?Journal of anaesthesia and intensive care medicine2019 ;9:2  
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary                                This is a randomized control study and aims to compare efficacy of two drugs lignocaine and dexmedetomidine with erector spinae block as opioid free anesthetic technique in lumbar spine surgeries. Primary objective of the study is to assess duration of analgesia between the two groups (lignocaine vs dexmedetomidine) in the postoperative period .The secondary objectives are to assess the hemodynamic parameters such as heart rate ,systolic blood pressure (SBP),diastolic blood pressure (DBP),mean arterial pressure and saturation ,to assess the total rescue analgesic (ketamine)consumed between two groups ,to assess total analgesic consumption of two groups, to assess severity of pain postoperatively using NRS score at rest and movement between two groups and to assess total dose of rescue analgesia used post operatively between two groups. The recruited patients will be randomized and allocated into two groups-Group L (control) and Group D (intervention )with 25 patients in each  by computer generated table .Group L will receive 1.5mg/kg  lignocaine bolus over 15 min followed by 1mg/kg/hr and Group D will receive 1 mcg/kg dexmedetomidine over 15 min followed by 0.5 mcg/kg/hr .Preoperatively oral gabapentin 600 mg will be given 1 hour prior to surgery .Erector spinae block is given at L2-3 vertebral level ,in plane technique in  a caudocranial direction .Hydro dissection is done to visualize  needle position deep to erector spinae muscle .After confirmation 40 ml of 0.25 % bupivacaine with 100 mcg/kg dexamethasone is injected bilaterally. Rescue  analgesia 0.5mg/kg ketamine is used intraoperatively if HR>20 % baseline and MAP>20% baseline .

The outcome variables and their measures 
intraoperatively
1)Hemodynamic parameters -HR .Blood pressure (SBP,DBP,MAP),SPO2 is monitored every 15 min until end of surgery
2)Total rescue analgesic (IV Ketamine)consumed at the end of surgery
30Total analgesic consumption of the study drugs 
Postoperatively
4)Severity of pain by using  NRS score both at rest and movement on arrival to PACU,20 min ,discharge from PACU ,2 hsr,4hrs,8hrs,12hrs and 24hrs 
5)Side effects like PONV ,sedation ,respiratory depression (respiratory rate<8) and desaturation (spo2<94%)on arrival to PACU ,20 min, discharge  from PACU ,2hrs,4hrs,,8hrs,12hrs,24hrs.
6)Total dose of IV PCA Fentanyl used at end of 24 hrs 
                           
                                         Descriptive and informative statistical analysis will be tabulated .Results on continues measurements are presented as Mean+_ SD Results on categorical measurements will be presented as number (%).Analysis of variance (ANOVA) will be used to find the significance of study parameters between the two groups of patients. Study ’t’ test will be used to find the significance of study parameters on continues scale within each group.Chi square /Fischer Exact test will be used to find significance of study parameters on categorical scale within two groups. 
 
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