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CTRI Number  CTRI/2021/09/036288 [Registered on: 07/09/2021] Trial Registered Prospectively
Last Modified On: 07/09/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   Effect of intravenous ketamine during spinal anaesthesia on duration of postoperative analgesia 
Scientific Title of Study   Efficacy of intravenous ketamine after spinal anesthesia on post-operative pain 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Spoorti Pujari 
Designation  Pg student 
Affiliation  Dr D Y Patil medical college,hospital and research center 
Address  Department of anaesthesia, old building. Ground floor ,Dr D Y Patil medical college, hospital and research centre, Sant tukaram Nagar, pimpri,pune
Department of anaesthesia, old building. Ground floor,Dr D Y Patil medical college, hospital and research centre, Sant tukaram Nagar, pimpri,pune
Pune
MAHARASHTRA
411018
India 
Phone  9620876754  
Fax    
Email  spoonish.pujari16@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Aparna Bagle 
Designation  Professor 
Affiliation  Dr D Y Patil medical college,hospital and research center 
Address  Department of anaesthesia, old building, Ground floor, Dr D Y Patil medical college, hospital and research centre, Sant tukaram Nagar, pimpri,pune
Department of anaesthesia, old building, Ground floor,Dr D Y Patil medical college, hospital and research centre, Sant tukaram Nagar, pimpri,pune
Pune
MAHARASHTRA
411018
India 
Phone  9620876754  
Fax    
Email  draparnabagle@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Spoorti Pujari 
Designation  Pg student 
Affiliation  Dr D Y Patil medical college,hospital and research center 
Address  Department of anaesthesia, old building, Ground floor,Dr D Y Patil medical college, hospital and research centre, Sant tukaram Nagar, pimpri,pune
Department of anaesthesia, old building, Ground floor, Dr D Y Patil medical college, hospital and research centre, Sant tukaram Nagar, pimpri,pune
Pune
MAHARASHTRA
411018
India 
Phone  9620876754  
Fax    
Email  spoonish.pujari16@gmail.com  
 
Source of Monetary or Material Support  
Central pharmacy, D Y Patil medical college 
 
Primary Sponsor  
Name  Dr D y Patil medical college hospital and research centet 
Address  Dr D Y Patil medical college, hospital and research centre, Sant tukaram Nagar, pimpri, pune 
Type of Sponsor  Research institution and hospital 
 
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 
Spoorti   D Y Patil medical college and research centre  Department of anaesthesia, old building,Ground floor,Dr D Y Patil medical college, hospital and research centre, Sant tukaram Nagar, pimpri, Pune
Pune
MAHARASHTRA 
9620876754

spoonish.pujari16@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics sub committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  ASA1 and ASA2 fit patients 
Patients  (1) ICD-10 Condition: 4||Measurement and Monitoring, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  ketamine   Intravenous ketamine administration 10mins after spinal anaesthesia. Intraoperative monitoring for hemodyanamic changes and postoperative VAS score and sedation score monitoring  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with ASA grade 1 or 2
Patients with all routine investigations within normal limits and with no comorbidities
Availability of informed consent 
 
ExclusionCriteria 
Details  patients with ASA grade 3 and above
Patients posted in emergency procedures
Patients with major neurological, cardiac, respiratory, metabolic, renal, hepatic diseases
Patients with allergies to study drug 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
VAS Score
Sedation score 
24hours 
 
Secondary Outcome  
Outcome  TimePoints 
Duration of analgesia  12hours 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   15/09/2021 
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="2"
Months="0"
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)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [spoonish.pujari16@gmail.com].

  6. For how long will this data be available start date provided 01-01-2022 and end date provided 01-01-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  

After approval from the institutional ethics committee, study will be conducted in 60 ASA I and ASA II fit patients scheduled for surgeries under spinal anaesthesia aged between 18 to 60 years of age, hemodynamically stable and  with informed consent. 60 patients equally divided into group N and group K in which group N receives normal saline intravenously and group K receives ketamine intravenously. Preoperative pulse, non-invasive blood pressure, ECG and oxygen saturation will be noted. Peripheral venous access will be established and intravenous (IV) fluids will be given, preloading will be with 10ml/kg of Ringer‟s lactate. The spinal anaesthesia will be given in the sitting position with due aseptic precautions. After painting and draping of the lumbar area, 2% xylocaine will be infiltrated in L3-L4 intervertebral space and a 26 G Quincke‟s spinal needle will be introduced. CSF free flow will be confirmed and intrathecal Inj. Bupivicaine 3ml(15mg) will be given. The patient will be placed supine position immediately and will be administered 2 litres of oxygen via a venture mask. Ascent of the sensory block will be checked by pin prick method. Motor blockade will be checked with bromage scale. 10minutes after spinal anaesthesia Inj.Midazolam 1mg will be given followed by study drug

Group (N) – 30 cases (5ml normal saline intravenously )

Group (K) – 30 cases (0.25mg/kg of Inj.ketamine diluted upto 5ml with normal saline intravenously)

All the vitals such as heart rate, mean arterial pressure,blood pressure,spo2  will be noted at 1min, 5mins and every 10mins after drug injection until the end of surgery

Any other side effects such as tachycardia, bradycardia, hypotension, nausea, vomiting, pruritis, headache will be noted and treated accordingly. Post-operatively visual analogue scale score (VAS) and sedation score will be noted every half hourly.

During the postoperative period, patients will be given Inj. Diclofenac 75mg i.m. stat on demand for rescue analgesia when the pain score is more than 5 on the basis of the Visual Analog Scale. Subsequent rescue analgesics will be given more than 5or more than 5. Time of administration of the rescue analgesic will be noted and chart will be maintained.


 
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