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CTRI Number  CTRI/2018/03/012658 [Registered on: 19/03/2018] Trial Registered Retrospectively
Last Modified On: 18/03/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Finding the concenteration of desflurane to induce sleep in 50% of children and blocking spinal nerves affects the concenteration of the same 
Scientific Title of Study   Determination of Minimum alveolar concentration of desflurane for maintaining BIS below 50 in children and the effect of caudal analgesia on it 
Trial Acronym  Determination of Minimum alveolar concentration of desflurane for maintaining BIS below 50 in children and the effect of caudal analgesia on it 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jeetinder Kaur Makkar 
Designation  ASSOCIATE PROFESSOR 
Affiliation  PGIMER 
Address  DEPARTMENT OF ANESTHESIA AND INTENSIVE AND INTENSIVE CARE, NEHRU HOSPITAL, CHANDIGARH

Chandigarh
CHANDIGARH
160012
India 
Phone  8847288105  
Fax    
Email  jeet1516@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Jeetinder Kaur Makkar 
Designation  ASSOCIATE PROFESSOR 
Affiliation  PGIMER 
Address  DEPARTMENT OF ANESTHESIA AND INTENSIVE AND INTENSIVE CARE, NEHRU HOSPITAL, CHANDIGARH

Chandigarh
CHANDIGARH
160012
India 
Phone  8847288105  
Fax    
Email  jeet1516@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Jeetinder Kaur Makkar 
Designation  ASSOCIATE PROFESSOR 
Affiliation  PGIMER 
Address  DEPARTMENT OF ANESTHESIA AND INTENSIVE AND INTENSIVE CARE, NEHRU HOSPITAL, CHANDIGARH

Chandigarh
CHANDIGARH
160012
India 
Phone  8847288105  
Fax    
Email  jeet1516@gmail.com  
 
Source of Monetary or Material Support  
Post graduate Institute of Medical Education and research institute  
 
Primary Sponsor  
Name  PGIMER 
Address  sector 12, chandigarh 
Type of Sponsor  Research institution and hospital 
 
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 
Jeetinder kaur makkar  Post Graduate Institute of Medical Education and Research Institute.   Advanced Pediatric centre, Operation room theatre complex.
Chandigarh
CHANDIGARH 
8847288105
8847288105
jeet1516@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ASA I-II children in between1-8 years of age undergoing elective infra-umbilical surgery under general anaesthesia ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group C   Group C Children were placed in left lateral position. Caudal block was performed with short beveled 23G needle using 0.75mL•kg-1 of 0.25% bupivacaine. Children were then turned supineand desflurane was administered in 100% oxygen at a predetermined concentration. We waited for 10 min for the onset of caudal block. Thereafter, on ataining same exhaled end-tidal desflurane concentration as predetermined inspired concentration with the aim to achieve equilibrium between the alveolar and brain concentration, BIS was recorded at an interval of 10sec for 1-min.  
Comparator Agent  Group D  Group D –After LMA insertion, children in this group were administered desflurane in 100% oxygen at a predetermined concentration. We waited until the exhaled end-tidal desflurane concentration attained the inspired desflurane concentration. BIS values were then recorded at an interval of 10sec for 1-min. Children in this group were then turned lateral and given caudal block for the purpose of intraoperative analgesia. Data recording for primary outcome was completed before start of surgery.  
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  Forty-five children of ASA status I-II between the age group of 1-8 years scheduled for elective infra-umbilical surgery under general anaesthesia during the study period (May 2014 to December 2014) were assessed for eligibility. 
 
ExclusionCriteria 
Details  Patients with history of respiratory or neurological disease were excluded from this study 
 
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 
Primary outcome of the study was to determine MACBIS50 of desflurane   After attainment of brain and alveolar equilibrium BIS of desflurane was recorded at an interval of 10 sec for 1 min 
 
Secondary Outcome  
Outcome  TimePoints 
Success rate of LMA removal, incidence of coughing and airway complications were the secondary outcomes studied.

 
observed intraoperatively 
 
Target Sample Size   Total Sample Size="39"
Sample Size from India="39" 
Final Enrollment numbers achieved (Total)= "39"
Final Enrollment numbers achieved (India)="39" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   01/05/2014 
Date of Study Completion (India) 31/12/2014 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Bispectral index (BIS) is an EEG derived parameter. Anesthetic agents are titrated to a specific BIS value during general anaesthesia to allow adjustment of the amount of anaesthetic agent required for adequate depth of anesthesia thus resulting in a more rapid emergence. Further, BIS monitoring reduces the incidence of intraoperative awareness under general anaesthesia in adults.

Anesthetic agents have a comparable effect on EEG throughout the life [1]. Though conceived as an adult tool, use of BIS for titrating the effect of anaesthesia in children has been supported in several studies [2-6].  Further, as in adults, BIS values in pediatric patients inversely correlate with end tidal concentration of sevoflurane and isoflurane [7, 8]. The minimum alveolar concentration of sevoflurane for maintaining BIS below 50 (MACBIS50) has been determined to be 2.83+/-0.16% in children [4]. The minimum alveolar concentration (MAC) of sevoflurane required to prevent purposeful movement in response to noxious stimuli in 50% of patients has been reported to be 2.4% in children [9]. Thus, the ratio of MACBIS50/MAC is 1.18 in pediatric patients. However, there have been no reports investigating these values for desflurane.

            Regional techniques have been shown to decrease the requirement of anaesthetics agents. There was 34% reduction in MACBIS50 of sevoflurane after administration of epidural lignocaine in adults [10]. No study has evaluated the effect of caudal anaesthesia on MACBIS50 of inhalational agent in children

            We hypothesized that caudal block will decrease the MACBIS50 of desflurane. Primary outcome of the study was to determine MACBIS50 of desflurane and effect of caudal block on it. Success rate of LMA removal, incidence of coughing and airway complications were the secondary outcomes studied. 

Results

Parents of 42 patients consented to participate in the study. Study protocol could not be followed in three patients. (Figure1) These three children were excluded before the inclusion of next patient. Table 1 shows the baseline patient characteristics of children in two groups. Fig. 2 shows the sequences of individual patients in both groups using up-and-down method. The MACBIS50 values calculated with the Dixon’s up-and-down method was significantly higher (p=0.0007) in Group D [5.75%(0.288)} than Group C [4.5%(0.381)]. Mean endtidal CO2 was comparable in both the groups.

A logistic regression curve of the probability of attaining BIS50 is shown in Figure 3 and 4 and is illustrated by the dose–response curve constructed for both groups using probit test data The MACBIS50 values estimated by probit analysis were 5.57% (95%CI 5.22 to 5.95) in Group D and 4.32%(95% CI 3.12 to 5.08) in Group C. Values were similar to those obtained with Dixon up down method. Corresponding ED95 values were 6.158 (5.85 to 8.04) for Group D and 5.18 (4.7 to 6.6) for Group C.


 
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