CTRI Number |
CTRI/2014/07/004769 [Registered on: 25/07/2014] Trial Registered Retrospectively |
Last Modified On: |
23/07/2014 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Comparison of intravenous dexmedetomidine and midazolam in patients undergoing monitored anaesthesia care during cataract surgery |
Scientific Title of Study
|
A comparative evaluation of intravenous dexmedetomidine and midazolam in patients undergoing monitored anaesthesia care during cataract surgery |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
Nil |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Deepak Thapa |
Designation |
Associate professor |
Affiliation |
Govt medical college and hospital chandigarh |
Address |
Department of anaesthesia and intensive care level 5 block D
government medical college and hospital
sector 32
chandigarh Chandigarh CHANDIGARH 160031 India |
Phone |
9646121524 |
Fax |
|
Email |
dpkthapa@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Neetika virender sahai |
Designation |
student |
Affiliation |
Govt medical college and hospital chandigarh |
Address |
Department of anaesthesia and intensive care level 5 block D
government medical college and hospital sector 32
Chandigarh
Chandigarh CHANDIGARH 160031 India |
Phone |
9999496559 |
Fax |
|
Email |
neetika_sahai@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
Dr Deepak Thapa |
Designation |
Associate professor |
Affiliation |
Govt medical college and hospital chandigarh |
Address |
Department of anaesthesia and intensive care level 5 block D
government medical college and hospital
sector 32
chandigarh Chandigarh CHANDIGARH 160031 India |
Phone |
9646121524 |
Fax |
|
Email |
dpkthapa@gmail.com |
|
Source of Monetary or Material Support
|
Government medical college and hospital sector 32 chandigarh |
|
Primary Sponsor
|
Name |
Government medical college and hospital |
Address |
Government medical college and hospital
sector 32
Chandigarh |
Type of Sponsor |
Government medical college |
|
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 Deepak Thapa |
Government medical college and hospital sector 32 chandigarh |
Government medical college and hospital block D level 5
sector 32
Chandigarh Chandigarh CHANDIGARH |
9646121524
dpkthapa@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Patients who are ASA grade 1 to 3 from 18 yrs to 80yrs and suffering from cataract of either eye, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Intravenous Dexmedetomidine
|
Mode of administration - intravenous.
Its is a sedative and analgesic agent devoid of respiratory depressant properties with a short half life of 2 hours .
patients in this group received an initial loading dose of dexmedetomidine in infusion over 10 minutes at 0.5 µg/kg using an infusion pump (from the 50ml syringe labeled as infusion drug) and to ensure blinding, a 3 ml bolus of normal saline (from the initial bolus’ syringe) was administered intravenously. This was followed by a continuous infusion of dexmedetomidine 0.1 -0.4µg/kg/hr starting at 0.2µg/ kg/hr and titrated every 10 minutes, in steps of 0.1µg/kg/hr to a Ramsay sedation scale of 3. Furthermore to maintain blinding, with each increment in the infusion rate of dexmedetomidine, normal saline 0.5 ml intravenous bolus was administered concomitantly (from the repeat boluses syringe ). This lasted till the end point of achieving ramsay sedation score of 3 |
Comparator Agent |
Intravenous Midazolam |
Mode of administration - intravenous.
Midazolam is a benzodiazipine with sedative and hypnotic activity commonly used in cataract surgery.
Patients in this group received normal saline the volume of which is calculated as if the patient is receiving dexmedetomidine intravenously over 10 min using infusion pump from the 50 ml syringe labeled infusion drug. This was along with midazolam 20µg/kg intravenous bolus (from the initial bolus syringe). This was followed by normal saline infusion starting at 0.1 ml/kg/hr and titrated every ten min in steps of 0.025 ml/kg/hr, to a Ramsay sedation scale of 3. In addition, with each increment in the infusion rate midazolam in doses of 0.5mg intravenous (from the repeat bolus syringe) was administered, till the sedation score of 3 was obtained in these patients.
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
80.00 Year(s) |
Gender |
Both |
Details |
1) Patients of either sex
2) ASA grade 1 to 3
3) Age group of 18 to 80 years scheduled for elective cataract surgery |
|
ExclusionCriteria |
Details |
Patients with
1. history of chronic use of sedatives
2. history of alcohol abuse
3. second and third degree heart block ,
4. significant cardio respiratory illness
5. history of sleep apnea
6. patients with BMI > 30 |
|
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 |
To compare and evaluate the effect of lower loading doses of dexmedetomidine sedation with those of midazolam sedation in patients undergoing cataract surgery under peribulbar anaesthesia |
baseline , 5 min , 10 min , immediately after block , 5 min after , 10 min after , 15 min after ,20 min after. postoperatively 5 ,10, 15, 30 and 45 minutes |
|
Secondary Outcome
|
Outcome |
TimePoints |
Comparison of hemodynamic parameters , sedation scores and post operative discharge criteria |
baseline , 5 min , 10 min , immediately after block , 5 min after , 10 min after , 15 min after ,20 min after. postoperatively 5 ,10, 15, 30 and 45 minutes |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
03/01/2011 |
Date of Study Completion (India) |
Date Missing |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="2" Months="0" 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
|
The present study was conducted in the Department of Anesthesia and Intensive Care,Government Medical College and Hospital, Chandigarh in collaboration with the department of Ophthalmology. After obtaining approval of institutional ethics committee and written informed consent, 60 patients (30 in each group) of either sex or ASA grade I - III, between 18 and 80 years of age and scheduled elective cataract surgery with MAC under local anaesthesia were enrolled. The present study was prospective, randomized, double blind and controlled study. After obtaining written informed consent, all patients were evaluated a day prior to surgery to assess the fitness for the proposed surgical procedure. Randomization of patients was done by using coded sealed envelopes and subsequently they were allocated to one of the following group of 30 each to receive either dexmedetomidine (Group D) or midazolam (Group M).
Group D patients had dexmedetomidine 4µg/ml in the 50 ml syringe and saline in other two syringes. Group M patients had saline in 50 ml syringe, and midazolam in 1mg/ml in the 5 ml syringe, and midazolam 20µg/kg premixed with saline to a total volume of 3 ml in the 3 ml syringe.
To ensure blinding, three syringes were used in all the patients in both the groups. The study drug was prepared in three maximally filled up coded syringes by a person not involved in study. The contents of syringe and group of the patients was unknown to the person administering the drug and the person involved in the data recordings. The codes were not be revealed until the completion of the study. After completing the loading of the study drug in both the groups, the ophthalmologist performed the peribulbar block. Phacoemulsification was performed and intraocular lens was implanted. HR, MAP, RR,oxygen saturation (SPo2) and expired CO2 was recorded every 5 minutes throughout the surgery. At the completion of surgery, in the recovery room, Modified Aldrete score was determined every 5, 10,15,30,45 min until discharge and the need for any postoperative analgesia (fentanyl in dose of 25 µg) was recorded using VAS. All adverse events including, but not limited to bradycardia (HR <60 beats /min), hypotension were recorded. Subjective sensation of nausea and vomiting, dryness of mouth and delirium were recorded according to their respective scores. Patients were deemed ready for discharge when Modified Aldrete score of ≥12 was achieved .
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