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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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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