| CTRI Number |
CTRI/2018/03/012704 [Registered on: 21/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
20/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparision of potency of muscle relaxant ‘vecuronium’ during isoflurane anesthesia and nitrous oxide anesthesia |
|
Scientific Title of Study
|
Evaluation of neuromuscular blockade with Vecuronium during general anesthesia with Oxygen : Nitrous oxide, Isoflurane vs Oxygen : Air, Isoflurane. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
vishanth boddu |
| Designation |
junior resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Old block,1st floor,Dept of Anesthesiology and critical care,
JIPMER,
gorimedu,
pondicherry-605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7094897008 |
| Fax |
|
| Email |
boddu.vishanth@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr srinivasan |
| Designation |
Associate professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
SSB OT complex, first floor, Dept of Anesthesiology and critical care,
Jawaharlal Institute of Postgraduate Medical Education & Research,
gorimedu.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
|
| Fax |
|
| Email |
srinidnb@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Drvishanth Boddu |
| Designation |
junior resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Old block,first floor, Dept of Anesthesiology and critical care,
Jawaharlal Institute of Postgraduate Medical Education & Research,
gorimedu,
pondicherry-605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7094897008 |
| Fax |
|
| Email |
boddu.vishanth@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal institute of postgraduate education and research,puducherry-605006 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal institute of postgraduate education and research |
| Address |
Old block, first floor. Dept ofAnesthesiology and critical care,
JIPMER. |
| 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 |
| Vishanth boddu |
Jawaharlal institute of postgraduate education and research |
Dept of Anesthesiology and critical care.
Pondicherry
PONDICHERRY |
7094897008
boddu.vishanth@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jawaharlal institute of postgraduate education and research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA1 and 2 patients, of age between 18-65yrs ,undergoing surgery for more than 1 hr, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients undergoing elective surgical procedures of more than one hour duration, requiring general anesthesia with muscle relaxation |
|
| ExclusionCriteria |
| Details |
1. Patient’s refusal.
2. Patients with hepatic or renal dysfunction.
3. Patients with neuromuscular disorders.
4. Patients on medication that may alter neuromuscular transmission.
5.Pregnant patients and patients above 65 years of age.
6. Contraindication to nitrous oxide, isoflurane or vecuronium
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Using neuro muscular monitoring,To assess and compare neuromuscular blockade of vecuronium during general anaesthesia with O2,N2O and isoflurane versus O2,air and isoflurane. |
PTC1-TOF1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Using neuro muscular monitoring,To assess and compare 1. block onset time of vecuronium in both the groups using the time taken for twitch height depression to become 30% of normal
2. from vecuronium administration to first appearance of PTC 1
3. PTC (n) at reappearance of 1st twitch in both the groups
4.time interval between TOF 1 and TOF 3
5.from vecuronium administration to appearance of TOF 3 |
post tetanic count-1(PTC1), Train of four-TOF1,TOF3,TOF1-TOF3. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/12/2017 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none as yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Conventionally balanced
anesthesia involves the use of inhalational agents and non depolarizing
agents. Isoflurane is added to nitrous
oxide at 66% to act as carrier gas. However as nitrous oxide can cause
distension of bowel due to its low solubility, the use of air with oxygen and
isoflurane has become common particularly in abdominal and laparoscopic
surgeries. When nitrous oxide is replaced by air, the percentage of isoflurane
is kept higher to ensure adequate depth of anesthesia. Inhalational agents have
variable effect on muscle relaxants and by themselves are also known to have an
effect on neuromuscular junction. Nitrous oxide also is known to
potentiate neuromuscular blockers . With varied mixture of gases and isoflurane used
in general anaesthesia ,the exact dosing requirement and time duration of
action has not been precisely studied with vecuronium when given as bolus as is
given routinely. Hence this study is undertaken to evaluate and compare the neuromuscular effect of vecuronium during
anaesthesia with oxygen, nitrous oxide (O2:N2O) and isoflurane and oxygen,air (O2:air) and
isoflurane.
Quantifying
the character of the block by neuromuscular monitoring by measuring single
twitch, post tetanic count (PTC), and train of four (TOF) can give precision of
the block and thereby better titration of drugs. Research
hypothesis (es): The character
of neuromuscular block with vecuronium will be same with nitrous oxide and without nitrous oxide,when used with isoflurane.
|