| 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
|
|
|
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
|
|
|
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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