| CTRI Number |
CTRI/2018/03/012327 [Registered on: 05/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
28/02/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
The effect of Dexmedetomidine on recovery after General Anaesthesia- a randomized controlled study |
|
Scientific Title of Study
|
Time course of psychomotor recovery after intravenous dexmedetomidine infusion as a part of balanced anaesthetic technique: A randomized, double-blind study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ayyappan C |
| Designation |
Junior resident |
| Affiliation |
JIPMER |
| Address |
Room no:301, Harvey house 2,
JIPMER hostel complex, JIPMER,
Puducherry
Room no:301, Harvey house 2,
JIPMER hostel complex, JIPMER,
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9894696456 |
| Fax |
|
| Email |
ayyappan.ibu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Kumar Mishra |
| Designation |
Additional Professor & Head |
| Affiliation |
JIPMER |
| Address |
Department of Anaesthesiology & Critical Care, Jawaharlal Institute of Postgraduate Medical Education & Research, Dhanvantri nagar
Department of Anaesthesiology & Critical Care, Jawaharlal Institute of Postgraduate Medical Education & Research, Dhanvantri nagar
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9344668104 |
| Fax |
91413-2296161 |
| Email |
jipmermishra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ayyappan C |
| Designation |
Junior resident |
| Affiliation |
JIPMER |
| Address |
Room no:301, Harvey house 2,
JIPMER hostel complex, JIPMER,
Puducherry
Room no:301, Harvey house 2,
JIPMER hostel complex, JIPMER,
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9894696456 |
| Fax |
|
| Email |
ayyappan.ibu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education & Research, Dhanvantri nagar, Puducherry 605006, India |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education Research |
| Address |
Dhanvantri nagar,
Puducherry 605006, Puducherry district, India |
| 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 |
| Dr Ayyappan C |
Jawaharlal Institute of Postgraduate Medical Education & Research |
Department of Anaesthesiology, Second floor, Old hospital building, Jawaharlal Institute of Postgraduate Medical Education & Research,Dhanvantri Nagar, Gorimedu, Puducherry 605006
Pondicherry
PONDICHERRY |
9894696456
ayyappan.ibu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JIPMER Institute ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients undergoing elective surgery under general anaesthesia of expected duration less than 2 hours, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DEXMEDETOMIDINE |
Dexmedetomidine was diluted in 50 ml of 0.9% saline as 2µg/ml concentration and loaded in an infusion pump. After induction of general anaesthesia and intubation, all participants received a loading dose of 0.5 ml/kg over 10 minutes & a maintenance infusion of 0.25 ml/kg/hr. Infusion was stopped during skin closure at the end of surgery. |
| Comparator Agent |
Normal saline |
0.9% saline was loaded in 50 ml syringe and loaded in a infusion pump. After induction of general anaesthesia and intubation, all participants received a loading dose of 0.5 ml/kg over ten minutes & a maintenance infusion of 0.25 ml/kg/hr. Infusion was stopped during skin closure at the end of surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 & 2 patients undergoing elective surgery of expected duration less than 2 hrs under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Patients refusing consent, known history of psychiatric illness, chronic drug or alcohol abuse, known hypersensitivity to drugs used, family history of malignant hyperthermia, significant cardiopulmonary, hepatic or renal disease, pregnant and breast feeding women, hypertensive patients not on any treatment or those treated with alpha or beta blockers and patients on concurrent sedative medications |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Psychomotor function was assessed by Trieger dot test (TDT) and Digit symbol substitution test (DSST). |
Both the tests were done pre-operatively (baseline), 30 minutes, 60 minutes, 90 minutes and 120 minutes after extubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total opioid requirement |
Fentanyl 1 µg/kg was supplemented whenever there was increase in patients heart rate or blood pressure by 30% from baseline in both the groups during surgery |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
16/04/2015 |
| Date of Study Completion (India) |
06/04/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
After informed consent, patients fulfilling the inclusion and exclusion
criteria will be randomized to two groups by computer generated random numbers.
Pre operatively, psychomotor function of the patient will be assessed with TDT
and DSST. Trieger dot test consists of joining 30 dots with a line to form a
figure within a time limit of 60 seconds. It is analyzed by number of dots
missed, maximum distance of dots missed and average number of dots missed. DSST
consists of matching digits with their corresponding symbol within a time
limit. The digits along with the corresponding symbols will be located in a
legend given at the top of the page. 9 such digits will be assigned symbols in
the legend. It is analyzed by the number of digits correctly matched with the
corresponding symbols within 90 seconds. On the day before surgery, both the
tests will be done thrice to familiarize it to the patient and fourth test will
be taken as the baseline psychomotor evaluation for that patient. In each of these patients, after attaching the routine monitors and
recording baseline parameters, anaesthesia will be induced with Propofol (up to
2.5 mg/kg) and Fentanyl (2µg/kg). Vecuronium (0.1mg/kg) will be given in both
groups and trachea intubated after 3 minutes. Dexmedetomidine will be diluted
to 2µg/ml in a total volume of 50 ml and will be blinded against an identical
volume of saline. After intubation, each patient’s receive a loading dose of
0.5 ml/kg over 10 minutes & a maintenance infusion of 0.25ml/kg/hr.
Anesthesia will be maintained by nitrous oxide 67% in oxygen and sevoflurane
whose MAC value will be adjusted to maintain an entropy value of 40 - 60. Supplemental
fentanyl will be given as clinically indicated. Fentanyl will not be
administered within 30 min of the end of surgery. Inhalational agents and infusions will be stopped at
the time of skin closure. TDT and DSST will be conducted at intervals of 30 minutes, 60 minutes,
90 minutes and 120 minutes after the end of the surgery. The clinician
performing the postoperative psychomotor analysis would be unaware of the drug
that had been administered to the patient. |