| CTRI Number |
CTRI/2021/04/032685 [Registered on: 08/04/2021] Trial Registered Prospectively |
| Last Modified On: |
30/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To known the effect of two different dose of iv dexamethasone on patients undergoing surgery under spinal anaesthesia. |
|
Scientific Title of Study
|
To evaluate the efficacy of two different doses of intravenous dexamethasone on the duration of subarachnoid block in patients undergoing infraumbilical surgery : A randomized control double blind study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Maya dehran |
| Designation |
Professor |
| Affiliation |
All India institute of medical sciences New delhi |
| Address |
Department of anaesthesiology,pain medicine and critical care,
Room no 5010(D), teaching block,Aiims, Ansari nagar, south Delhi
South
DELHI
110029
India |
| Phone |
8800497195 |
| Fax |
|
| Email |
Mayadehran@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Maya dehran |
| Designation |
Professor |
| Affiliation |
All India institute of medical sciences New delhi |
| Address |
Department of anaesthesiology,pain medicine and critical care,
Room no 5010(D), teaching block,Aiims, Ansari nagar, south Delhi
South
DELHI
110029
India |
| Phone |
8800497195 |
| Fax |
|
| Email |
Mayadehran@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Sumanth S |
| Designation |
Junior resident |
| Affiliation |
All India institute of medical sciences New delhi |
| Address |
Department of anaesthesiology,Pain Medicine and Critical care,Aiims,Ansari nagar ,110029
South
DELHI
110029
India |
| Phone |
9880561112 |
| Fax |
|
| Email |
Sumanth.tmk96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology,Pain Medicine and Critical care,Aiims,Ansari nagar ,New Delhi,110029 |
|
|
Primary Sponsor
|
| Name |
DR MAYA DEHRAN |
| Address |
Department of anaesthesiology,Pain Medicine and Critical care,Aiims,Ansari nagar ,110029 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Department of anaesthesiologyPain Medicine and Critical care |
Aiims,Ansari nagar,New Delhi ,110029 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Maya Dehran |
Aiiims, new delhi |
Department of anaesthesiology, Pain medicine and critical care,AB8 Ot complex, Aiims hospital, New Delhi
110029
South
DELHI |
8800497195
Mayadehran@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics sub committee,all India institute of medical sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexamthasone |
Intravenous Dexamethasone 4mg or 8mg,according to the patient group will be given during the subarachnoid block. |
| Comparator Agent |
Normal Saline |
2ml of normal saline will be given to control group during the subarachnoid block |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2, infra umbilical surgery,duration of surgery less than or equal to 3hrs, BMI less than or equal to 30 |
|
| ExclusionCriteria |
| Details |
Patient refusal,long term steroid therapy,allergy to dexamethasone,patient with diabetes mellitus,alcoholic abuse,addiction t opioids and chronic use of other analgesic drug,neurological and psychological disorders, chronic back ache,sepsis,infection at local site. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of sensory and motor blockade during subarachnoid block |
Sensory blockade will be till 4 dermatomes regression.motor block from bromage score 0 to 3. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Time of onset of sensory block and motor blockage.
2) Duration of post op analgesia and total dose of analgesic needed in first 24hr.
3) Effect on blood sugar levels.
4) Haemodynamics and other side effects – Post operative nausea and vomiting (PONV), itching and respiratory depression.
5) Ramsay sedation score for level of sedation.
|
1)Onset time of sensory block will be defined as the time from injection of drugs into the intrathecal space to peak of sensory blockade.Onset of motor block will be defined as the time from intrathecal injection of drug until the modified Bromage scale is 3.
2) The time to the first bolus dose will be recorded as the first analgesic requirement during first 24 hours.
|
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/04/2021 |
| Date of Study Completion (India) |
21/06/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
21/06/2022 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Introduction
The subarachnoid
block is the most commonly used block for infraumbilical surgeries. This helps
in avoiding risks of general anaesthesia like difficulty in airway management,
gastric aspiration and nausea and vomiting [1]. Local anaesthetic, Bupivacaine
is appropriate for procedures of 90-180 minutes duration.
Many additives have
been used so far to improve the onset and quality of subarachnoid block. These
medications improves quality and duration of sensory block. Various additives
like opioids, clonidine, ketamine , dexmedetomedine and many
more have been used .
Dexamethasone relieves
pain by reducing inflammation, blocking transmission of nociceptive c-fibers
and by suppressing ectopic neural discharge [2]. In addition it also increases the duration of
post operatives analgesia, when given iv with the local anaesthestics in subarachnoid
block , few studies shows
significant prolongation of subarachnoid
block while using dexamethasone as additive [3,4].
Few studies published
in the literature had shown the effect of addition of intravenous dexamethasone
on subarachnoid block duration, post-operative analgesia and reduced analgesic
requirement [3, 5].
Purpose of this
study- To evaluate the
effect of two different doses of IV dexamethasone with intrathecal bupivacaine
on prolongation of duration and quality of analgesia of subarachnoid block in
patients undergoing infraumbilical surgery. Why we choose this study:
Some studies have shown
that intravenous dexamethasone with intrathecal bupivacaine in LSCS (lower
section cesarean section), it significantly prolongs the duration of sensory
block and post op analgesia [3].
We didn’t find any study
using two different doses of IV dexamethasone in subarachnoid block.
As for spinal it
requires preservative free dexamethasone which will be difficult to get in
India. So we decided to use dexamethasone by intravenous route.
Reference 1)
Brown DL. Miller’s
anesthesia. Elsevier Churchill Livingstone. 2005;43:1653-83. 2) Golwala MP,
Swadia VN, Aditi A, Dhimar, Sridbar NV. Pain relief by dexamethasone as an
adjuvantto local anesthetics in supraclavicular brachial plexus block. J Anesth
Clin Pharmacol. 2009;25:285–8. 3) Shalu PS, Ghodki PS. To Study the Efficacy of
Intravenous Dexamethasone in Prolonging the Duration of Spinal Anesthesia in
Elective Cesarean Section. Anesth Essays Res. 2017 Apr-Jun;11(2):321-325. doi:
10.4103/0259-1162.194537. PMID: 28663614; PMCID: PMC5490098. 4) Bani-Hashem N, Hassan-Nasab B, Pour EA, Maleh
PA, Nabavi A, Jabbari A. Addition of intrathecal Dexamethasone to Bupivacaine
for spinal anesthesia in orthopedic surgery. Saudi J Anaesth. 2011
Oct;5(4):382-6. doi: 10.4103/1658-354X.87267. PMID: 22144925; PMCID:
PMC3227307.
5) Kadur,
S.N. & Ahmed, F. & Purohit, A. & Khandelwal, M. & Mistry,
Tuhin. (2015). The effect of intravenous dexamethasone on postoperative pain,
nausea and vomiting after intrathecal pethidine and bupivacaine in lower limb
orthopedic surgery. 19. 254-259.
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