| 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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
|
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 |
|
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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
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- 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.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [spoonish.pujari16@gmail.com].
- 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.
- 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 l Group (N) – 30 cases (5ml normal saline intravenously ) l 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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