| CTRI Number |
CTRI/2018/03/012630 [Registered on: 19/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
15/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To study the effects of sedative drug- dexmedetomidine- during general anaesthesia for endoscopic pituitary surgery. |
|
Scientific Title of Study
|
The effect of intravenous dexmedetomidine on intraoperative surgical bleeding and haemodynamics during trans-sphenoidal pituitary surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Preethy J Mathew |
| Designation |
Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care,PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9417800203 |
| Fax |
|
| Email |
tjpreethy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Preethy J Mathew |
| Designation |
Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care,
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9417800203 |
| Fax |
|
| Email |
tjpreethy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aparna Jain |
| Designation |
Junior Resident |
| Affiliation |
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care,
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09214540025 |
| Fax |
|
| Email |
jain.aprna@gmail.com |
|
|
Source of Monetary or Material Support
|
| Postgraduate Institute of Medical Education and Research (PGIMER)
Sector 12, Chandigarh- 160012 |
|
|
Primary Sponsor
|
| Name |
PGIMER Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, PGIMER, Chandigarh |
| 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 |
| Preethy J Mathew |
PGIMER, Chandigarh |
Department of Anaesthesia and Intensive Care,
PGIMER, Chandigarh
Chandigarh
CHANDIGARH |
7087009530
tjpreethy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PGIMER thesis committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Scheduled for trans-sphenoidal pituitary surgery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine Group |
Patients in this group received i.v. dexmedetomidine 1 µg/kg over a 10-min period before induction of anesthesia and 0.5µg/kg/hr by continuous i.v. infusion during the procedure from the beginning of anaesthesia till the end of procedure. |
| Comparator Agent |
Placebo group |
Patients in this group received normal saline as placebo for i.v. bolus and maintenance infusion from the beginning of anaesthesia till the end of the procedure |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
40 ASA I-II patients between 18-65 years of age, scheduled for elective trans-sphenoidal pituitary surgery |
|
| ExclusionCriteria |
| Details |
Patients with following conditions:
1.Decreased level of consciousness
2.Increased intracranial pressure
3.Risk of impending cerebral herniation 4.Anticipated elective postop ventilation
5.Co-existing intracranial lesions like aneurysms or arteriovenous malformations
6.Significant cardiovascular co-morbidity like unstable angina, recent myocardial infarction, coronary artery bypass surgery, refractory arrhythmias, severe hypertension, congestive heart failure,
7.Those with severe respiratory disease such as bronchial asthma
8.Those with body weight more than 130% of ideal body weight |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Haemodynamic changes in mean arterial blood pressure and heart rate |
During procedure-every 10 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Bleeding in surgical field |
During procedure |
| Isoflurane requirement |
During procedure |
| Recovery parameters |
Immediate postop |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/12/2010 |
| Date of Study Completion (India) |
29/07/2011 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A prospective randomized double blind study was
conducted in 40 ASA I-II patients between 18-65 years of both sexes, undergoing
elective trans-sphenoidal surgery for pituitary tumors. In this study we
compared the effect of dexmedetomidine and placebo on intra operative
hemodynamics of patients including SBP, DBP, MAP, HR, as well as effects
on intraoperative bleeding, requirement of intraoperative analgesia/
anaesthesia and recovery profile.
The changes in heart
rate were not significantly different from the baseline in Group D throughout
the procedure and there was significant increase in HR in Group P after
extubation (p<0.05). MAP decreased significantly from baseline at 5
minutes after local infiltration and at 30, 40, 50, 60 and 70 minutes after
start of surgery in group D (p<0.05). In group P, though the MAP decreased,
the magnitude of decrease was not significant from the
baseline. On comparing the two groups, increase in HR in
response to intubation was significantly blunted in Group D. HR was
consistently lower and controlled in Group D during surgery though the
difference was not statistically significant. The absolute values of MAP were
lower and in the clinically desirable range of 75-85 mm Hg in Group
D.
|