| CTRI Number |
CTRI/2021/07/034595 [Registered on: 05/07/2021] Trial Registered Prospectively |
| Last Modified On: |
04/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The effectiveness of intravenous dexmeditomidine versus lignocaine on perioperative haemodynamics in patients undergoing laparoscopic cholecystectomy |
|
Scientific Title of Study
|
Comparision of attenuation of haemodynamic response to pneumo peritoneum by either Dexmeditomidine or lignocaine infusion administered to patients undergoing laparoscopic cholecystectomy -A Prospective Randomized double blind trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
B Manjusree |
| Designation |
MD Anaesthesia |
| Affiliation |
SVIMS |
| Address |
Department of Anaesthesia
SVIMS
TIRUPATI
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
8886946282 |
| Fax |
|
| Email |
manjuyashu1492@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hemanth Natham |
| Designation |
Professor |
| Affiliation |
SVIMS |
| Address |
Department of Anaesthesia
SVIMS
TIRUPATI
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9440285634 |
| Fax |
|
| Email |
hemanthn1973@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hemanth Natham |
| Designation |
Professor |
| Affiliation |
SVIMS |
| Address |
Department of Anaesthesia
SVIMS
TIRUPATI
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9440285634 |
| Fax |
|
| Email |
hemanthn1973@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NOT APPLICABLE |
| Address |
NOT APPLICABLE |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| Manjusree |
SRI VENKATESWARA INSTITUTE OF MEDICAL SCIENCES |
SRI VENKATESWARA INSTITUTE OF MEDICAL SCIENCES
VALMIKI CIRCLE,ALIPIRI ROAD
TIRUPATI,CHITTOOR DISTRICT
Chittoor
ANDHRA PRADESH |
8886946282
manjuyashu1492@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE OF SRI VENKATESWARA INSTITUTE OF MEDICAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K810||Acute cholecystitis. Ayurveda Condition: NOT APPLICABLE, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Attenuation of haemodynamic response to pneumo peritoneum by giving dexmeditomidine or lignocaine |
In Dexmeditomidine group patients will receive inj .dexmeditomidine @ 0.4 mcg/kg/hr and in Lignocaine group patients will receive inj lignocaine @ 2.0 mg /kg /hr intra venously till the last skin suture of the incision |
| Comparator Agent |
Attenuation of haemodynamic response to pneumo peritoneum by giving dexmeditomidine or lignocaine |
lignocaine 2mg/kg or dexmeditomidine 4micrograms /kg /hour will be given and haemodynamics will be monitored |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologists physical status I,II,III
2)Patients with age :20 TO 60 Years.
3) BMI ≤30 kg/m2
4)Patients undergoing elective laparoscopic cholecystectomy (non malignant) .
|
|
| ExclusionCriteria |
| Details |
1)Patients refusal
2)Patients with uncontrolled cardio respiratory, renal, hepatic or endocrine disease
3)Conversion of laparoscopic to open cholecystectomy
4)Patients with drains placed insitu.
5)Patients who are unable to perform VAS scale.
6)Surgical time exceeding 150 min.
7)Pregnant and lactating women.
8)Patients who are on Beta adrenergic blocker therapy.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the attenuation of blood pressure and heart rate response to pneumo peritoneum in patients undergoing laparoscopic cholecystectomy |
the first requirement of analgesic dose within 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the post operative sedation score between two groups
To assess and compare the Time to first request for analgesia post operatively.-defined as whenever the patient complains of pain or when visual analogue score
Number of propofol boluses required peri operatively.
Number of episodes of hypertension and hypotension peri operatively.
Number of doses of atropine, ephedrine, phenyl ephrine required intra operatively.
|
15,30,60minutes,2,3,4hours |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
19/07/2021 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To study the haemodynamic response to pneumo peritonium while administering infusions of either dexmeditomidine or lignocaine.dexmeditomidine blunts the hemodynamic response to pneumo peritoneum.lignocaine decreases post operative pain.to compare these drugs and their hemodynamic responses |