| CTRI Number |
CTRI/2026/02/104368 [Registered on: 20/02/2026] Trial Registered Prospectively |
| Last Modified On: |
19/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A study comparing the pain relieving effects of two medicines, dexmedetomidine and lignocaine after keyhole gallbladder removal surgery in patients of age group from 18 to 65 years old. Also to assess the difference in the heart rate, blood pressure during surgery between the two drugs. |
|
Scientific Title of Study
|
Comparison between the efficacy of intravenous dexmedetomidine vs intravenous lignocaine on post operative analgesia in patients undergoing laparoscopic cholecystectomy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manchala Jyothi Sai Reddy |
| Designation |
Post graduate student |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Department of Anaesthesiology, Kasturba medical college, light house hill road, hampankatta, mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
7981391697 |
| Fax |
|
| Email |
jyothisaireddy1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Kavya Prabhu |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
Department of Anaesthesiology, Kasturba medical college, light house hill road, hampankatta, mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
|
| Fax |
|
| Email |
Kavya.prabhu@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Manchala Jyothi Sai Reddy |
| Designation |
Post graduate student |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Department of Anaesthesiology, Kasturba medical college, light house hill road, hampankatta, mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
7981391697 |
| Fax |
|
| Email |
jyothisaireddy1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, light house hill road, hampankatta, mangalore, dakshina kannada, 575001, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Dr Manchala Jyothi Sai Reddy |
| Address |
Kasturba Medical College, light house hill road, hampankatta, mangalore, dakshina kannada, 575001, Karnataka, India |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manchala Jyothi Sai Reddy |
KMC Hospital Attavar |
Department of Anaesthesiology, KMC hospital, Attavar, Mangalore
Dakshina Kannada
KARNATAKA |
7981391697
jyothisaireddy1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC_Kasturba_Medical_College_Mangalore |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K804||Calculus of bile duct with cholecystitis, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
Route of administration-
intravenous dexmedetomidine
Loading Dose-
1 µg/kg IV
Administered over 10 minutes
Given once prior to induction of anesthesia
Maintenance Infusion-
0.5 µg/kg/hour IV infusion
Continuous infusion using infusion pump
Frequency-
Single loading dose followed by continuous infusion intraoperatively
Total Duration of Administration-
From initiation before induction
Continued throughout surgery
Discontinued at release of pneumoperitoneum |
| Comparator Agent |
Lignocaine |
Route of administration-
Intravenous lignocaine
Loading Dose-
1.5 mg/kg IV
Given as slow bolus over 90 seconds
Administered once prior to induction
Maintenance Infusion-
1 mg/kg/hour IV infusion
Continuous infusion using infusion pump
Frequency-
Single bolus dose followed by continuous infusion intraoperatively
Total Duration of Administration-
Started before induction
Continued during surgery
Discontinued at release of pneumoperitoneum |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients aged 18 to 65 years of either sex with the American Society of Anesthesiologists physical status classes 1 and 2 undergoing elective laparoscopic cholecystectomy surgery. |
|
| ExclusionCriteria |
| Details |
1)Patients unwilling to participate in the study.
2)Patients with BMI more than 35 kgm2
3)History of hypersensitivity to the drugs
4)Parturient
5)Chronic use of opioids or opioid addiction, steroids.
6)Inability to comprehend postoperatively for the pain assessment scale or neuropsychiatric disorders.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
1) Duration of analgesia
2) VAS score
|
Intraoperative assessment done at Baseline, After boluses of study drugs, Immediately after ETI, 5min, 15min, 30min, 45m, 1h, 1h15m, 1h30m, 1h45m, 2h, until the pneumoperitoneum is released.
Postoperatively assessed at 1hr, 4hr, 8hr, 12hr, and upto 24 hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Intraoperative Hemodynamic parameters at baseline, after boluses of drugs administration, immediately after intubation, 5min & every 15min until the end of the procedure.
2) Side effects like nausea, vomiting & sore throat.
3) Early ambulation.
4) Patient satisfaction using surgical satisfaction questionnaire 8 (SSQ-8).
|
Intraoperative assessment done at Baseline, After boluses of study drugs, Immediately after ETI, 5min, 15min, 30min, 45m, 1h, 1h15m, 1h30m, 1h45m, 2h, until the pneumoperitoneum is released.
Postoperatively assessed at 1hr, 4hr, 8hr, 12hr, & upto 24hours |
|
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Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/03/2026 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
|
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 - 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 - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [jyothisaireddy1@gmail.com].
- For how long will this data be available start date provided 19-06-2027 and end date provided 19-06-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
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Brief Summary
|
This is a prospective observational study to compare intraoperative hemodynamic stability and postoperative analgesia using Intravenous lignocaine vs intravenous dexmedetomidine in patients undergoing laparoscopic cholecystectomy. The study is planned to be conducted at a tertiary hospital in Dakshina Kannada. The study
will be carried out on patients aged 18 to 65 years of ASA grade I and II
undergoing laparoscopic cholecystectomy. The study has already cleared the institutional ethics committee approval.
|