| CTRI Number |
CTRI/2024/04/066529 [Registered on: 30/04/2024] Trial Registered Prospectively |
| Last Modified On: |
27/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To evaluate the effect of Metoclopramide -a prokinetic and anti emetic drug on the gastric volume after adequate fasting in patients undergoing gynaecological surgeries after spinal anaesthesia |
|
Scientific Title of Study
|
To evaluate the effect of metoclopramide on gastric reserve volume after adequate fasting (8 hours for solids, 2 hours for clear fluids) in patients undergoing gynaecological surgeries under subarachnoid block in a double blind and randomised clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Alisha Katwal |
| Designation |
Junior Resident |
| Affiliation |
Dr Rajendra Prasad Government Medical College Kangra at Tanda |
| Address |
Dept of Anaesthesia
Dr Rajendra Prasad Government Medical College Kangra at Tanda
Kangra
Himachal Pradesh
India
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9760792453 |
| Fax |
|
| Email |
alishakatwal3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shelly Rana |
| Designation |
Professor |
| Affiliation |
Dr Rajendra Prasad Government Medical College Kangra at Tanda |
| Address |
Dept of Anaesthesia
Dr Rajendra Prasad Government Medical College Kangra at Tanda
Himachal Pradesh
India
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418113786 |
| Fax |
|
| Email |
shelgnbj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shelly Rana |
| Designation |
Professor |
| Affiliation |
Dr Rajendra Prasad Government Medical College Kangra at Tanda |
| Address |
Dept of Anaesthesia
Dr Rajendra Prasad Government Medical College Kangra at Tanda
Himachal Pradesh
India
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418113786 |
| Fax |
|
| Email |
shelgnbj@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr RPGMC Kangra at Tanda |
| Address |
Dept of Anaesthesia
Dr Rajendra Prasad Government Medical College Kangra at Tanda
Himachal Pradesh 176001 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Alisha Katwal |
Dr Rajendra Prasad Government Medical College Kangra at Tanda |
Dept of Anaesthesia
Dr Rajendra Prasad Government Medical College Kangra at Tanda
Himachal Pradesh 176001
Kangra
HIMACHAL PRADESH |
970792453
alishakatwal3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr Rajendra Prasad Government Medical College Tanda at Kangra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N939||Abnormal uterine and vaginal bleeding, unspecified, (2) ICD-10 Condition: N819||Female genital prolapse, unspecified, (3) ICD-10 Condition: N72||Inflammatory disease of cervix uteri, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Injection metoclopramide |
Dose-10mg
Frequency-once in the preoperative period
Route- Intravenous
duration of therapy-usg reading taken 30 minutes after intervention |
| Comparator Agent |
Normal saline |
dose- 10 ml
frequency-once in the preoperative period
Route-Intravenous
duration of therapy-usg reading taken 30 min after the comaparator agent is given |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
ASA class I and II
BMI 18.5 – 29.9 kg/m2
Mallampati I or II
|
|
| ExclusionCriteria |
| Details |
1. Patients’ refusal for SAB
2. Patients with cardiovascular or respiratory disorders, diabetes, hypertension
3. Obesity( BMI>29.9kg/m2)
4. Abnormality of upper gastrointestinal tract(GIT) and history of GIT related surgical procedures in the past
5. Use of drugs affecting gastric motility
6. Need for general anaesthesia (GA) due to partial effect of SAB
7. Any contraindication to SAB
8. Cognitive impaired patients
9. History of prolonged QT interval or neuropsychiatric illness
|
|
|
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 |
| The primary outcome will be to observe the quantitative and qualitative change in gastric antrum as assessed by the US of gastric antrum to estimate gastric volume after standard dose of metoclopramide ie calculation of CSA in right lateral and supine position |
baseline and 30 minutes after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Incidence of complete gastric emptying
2.Incidence of episodes of intraoperative and postoperative nausea and vomiting after gynaecological surgeries correlated with Metoclopramide administration and gastric volume
3.Adverse outcomes-Number of adverse events like abdominal cramping, extrapyramidal symptoms between the two group
|
24 hours after administration of drug |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/05/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
this study will assess the effectiveness of preoperative injection metoclopramide on the gastric residual volume with the help of US guided assessment of gastric residual volume at baseline and 30 minutes after the drug. This study will also observe the effect of fasting duration on gastric volume |