UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063402 |
|---|---|
| Receipt number | R000072566 |
| Scientific Title | COMPARISON OF THE EFFECTS OF INTRAVENOUS LIGNOCAINE AND KETAMINE ON POSTOPERATIVE ANALGESIA UNDER GENERAL ANAESTHESIA: A PROSPECTIVE, RANDOMIZED, DOUBLE BLIND STUDY |
| Date of disclosure of the study information | 2026/10/24 |
| Last modified on | 2026/10/24 20:47:01 |
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Basic information
Public title
COMPARISON OF THE EFFECTS OF INTRAVENOUS LIGNOCAINE AND KETAMINE ON POSTOPERATIVE ANALGESIA UNDER GENERAL ANAESTHESIA: A PROSPECTIVE, RANDOMIZED, DOUBLE BLIND STUDY
Acronym
COMPARISON OF THE EFFECTS OF INTRAVENOUS LIGNOCAINE AND KETAMINE ON POSTOPERATIVE ANALGESIA UNDER GENERAL ANAESTHESIA: A PROSPECTIVE, RANDOMIZED, DOUBLE BLIND STUDY
Scientific Title
COMPARISON OF THE EFFECTS OF INTRAVENOUS LIGNOCAINE AND KETAMINE ON POSTOPERATIVE ANALGESIA UNDER GENERAL ANAESTHESIA: A PROSPECTIVE, RANDOMIZED, DOUBLE BLIND STUDY
Scientific Title:Acronym
COMPARISON OF THE EFFECTS OF INTRAVENOUS LIGNOCAINE AND KETAMINE ON POSTOPERATIVE ANALGESIA UNDER GENERAL ANAESTHESIA: A PROSPECTIVE, RANDOMIZED, DOUBLE BLIND STUDY
Region
| Asia(except Japan) |
Condition
Condition
POSTOPERATIVE PAIN FOLLOWING SURGERY UNDER GENERAL ANAESTHESIA
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the postoperative analgesic effects of intravenous lignocaine and ketamine, with normal saline as a control, in patients undergoing surgery under general anaesthesia. The study aims to assess postoperative pain intensity using Visual Analogue Scale (VAS) scores at specified time intervals, total opioid consumption during the first 24 hours after surgery, and time to first rescue analgesia administration. Secondary objectives include comparing haemodynamic parameters, including systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate, and evaluating postoperative recovery using the modified Aldrete score
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Postoperative pain intensity: Visual Analogue Scale (VAS) scores measured at predefined postoperative time intervals during the first 24 hours after surgery.
2. Total opioid consumption: Total opioid consumption during the first 24 hours after surgery, compared among the intravenous lignocaine, intravenous ketamine, and normal saline groups.
3. Time to first rescue analgesia: Time from the end of surgery to the first administration of rescue analgesia, compared among the three study groups.
Key secondary outcomes
1. Haemodynamic parameters, including systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), and heart rate (HR), measured at predefined time intervals.
2. Postoperative recovery profile assessed using the modified Aldrete score at the specified assessment time.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Participants received intravenous lignocaine 1.5 mg/kg as a bolus dose at induction of general anaesthesia, followed by continuous intravenous infusion of lignocaine 1.5 mg/kg/h during surgery under general anaesthesia
Interventions/Control_2
Participants received intravenous ketamine 0.15 mg/kg as a bolus dose at induction of general anaesthesia, followed by continuous intravenous infusion of ketamine 0.15 mg/kg/h during surgery under general anaesthesia
Interventions/Control_3
Participants received intravenous 0.9% normal saline as a bolus at induction of general anaesthesia, followed by continuous intravenous infusion of normal saline during surgery under general anaesthesia
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients of both sexes.
Patients aged 18 to 60 years.
Patients belonging to ASA physical status I and II.
Patients undergoing elective surgical procedures under general anaesthesia with a duration not exceeding three hours.
Patients who provided written informed consent to participate in the study.
Key exclusion criteria
Patients with known drug allergy or hypersensitivity to lignocaine or ketamine.
Patients with comorbidities including systemic hypertension, cardiac arrhythmias, diabetes mellitus, chronic obstructive pulmonary disease, or coronary artery disease.
Patients with hepatic or renal impairment.
Patients receiving calcium channel blockers or antihypertensive medications.
Patients who refused to provide consent for participation in the study.
Target sample size
72
Research contact person
Name of lead principal investigator
| 1st name | HIMALINIKUMARI |
| Middle name | ASHWINKUMAR |
| Last name | PATEL |
Organization
ANANTA INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE
Division name
DEPARTMENT OF ANAESTHESIOLOGY
Zip code
313202
Address
National Highway 58, Dist.- Tantela, Rajsamand, Rajasthan, India
TEL
6354538614
drhimalinipatel@gmail.com
Public contact
Name of contact person
| 1st name | HIMALINIKUMARI |
| Middle name | ASHWINKUMAR |
| Last name | PATEL |
Organization
ANANTA INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE
Division name
DEPARTMENT OF ANAESTHESIOLOGY
Zip code
313202
Address
National Highway 58, Dist.- Tantela, Rajsamand, Rajasthan, India
TEL
63545538614
Homepage URL
drhimalinipatel@gmail.com
Sponsor or person
Institute
ANANTA INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE
Institute
Department
Personal name
Funding Source
Organization
ANANTA INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
ANANTA INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE
Address
National Highway 58, Dist.- Tantela, Rajsamand, Rajasthan, India
Tel
+91 6354538614
drhimalinipatel@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
72
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 04 | Month | 06 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 10 | Month | 24 | Day |
Last modified on
| 2026 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072566
