CTRI Number |
CTRI/2020/06/025687 [Registered on: 08/06/2020] Trial Registered Prospectively |
Last Modified On: |
06/06/2020 |
Post Graduate Thesis |
No |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Single Arm Study |
Public Title of Study
|
A study to assess the rate of occurence of nausea and vomiting followed by the addition of the drug morphine given as apart of anaesthesia for patients with carcinoma cervix undergoing high dose (HDR) intracavitary brachytherapy. |
Scientific Title of Study
|
Prospective observational study to assess the incidence of nausea and vomiting following intrathecal morphine given as apart of anaesthesia for patients with carcinoma cervix undergoing high dose rate (HDR) intracavitary brachytherapy.
|
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
nil |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Divya Isac |
Designation |
Assistant professor |
Affiliation |
Christian Medical College |
Address |
Department of Anaesthesia
Christian Medical College
vellore
Vellore TAMIL NADU 632004 India |
Phone |
944300580 |
Fax |
|
Email |
divyaishac@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Divya Isac |
Designation |
Assistant professor |
Affiliation |
Christian Medical College |
Address |
Department of Anaesthesia
Christian Medical College
vellore
Vellore TAMIL NADU 632004 India |
Phone |
944300580 |
Fax |
|
Email |
divyaishac@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Divya Isac |
Designation |
Assistant professor |
Affiliation |
Christian Medical College |
Address |
Department of Anaesthesia
Christian Medical College
vellore
Vellore TAMIL NADU 632004 India |
Phone |
944300580 |
Fax |
|
Email |
divyaishac@gmail.com |
|
Source of Monetary or Material Support
|
Christian Medical College,Vellore,Tamilnadu |
|
Primary Sponsor
|
Name |
Christian MedicalCollegeVellore |
Address |
Ida Scudder Road,Vellore Town |
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 |
Divya Isac |
ChristianMedicalCollege,Vellore |
1) Department of Anaesthesia Centenary Block Operation rooms
2)Department of Radiotherapy - R ward
Ida Scudder Road,
Vellore Town Vellore TAMIL NADU |
9443000580
divyaishac@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Review Board |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: C539||Malignant neoplasm of cervix uteri, unspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Nil |
Nil |
Intervention |
Nil |
Nil |
|
Inclusion Criteria
|
Age From |
30.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Female |
Details |
1) Histologically proven carcinoma cervix for
intracavitary brachytherapy.
2) ASA I/II
3) Consent for participation in study |
|
ExclusionCriteria |
Details |
1) Patient undergoing treatment for chronic
pain
2) Preoperative history of nausea and vomiting
requiring treatment
3) Unfit for spinal anaesthesia like
Coagulopathy, cardiac lesions, infection at
the site of spinal injection, fever
4) Unwilling or unable to give consent |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Incidence of nausea and vomiting following intrathecal morphine
among patients coming for HDR Brachytherapy for carcinoma cervix |
With in 24 hours |
|
Secondary Outcome
|
Outcome |
TimePoints |
i) Duration of analgesia with intrathecal morphine which will be measured by
the time to first rescue analgesic
ii) Incidence of side effects like sedation, pruritus, respiratory depression
measured by sedation score, monitoring of respiratory rate and oxygen saturation at
regular intervals |
With in 24 hrs of induction |
|
Target Sample Size
|
Total Sample Size="200" Sample Size from India="200"
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)
|
08/06/2020 |
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="11" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Women diagnosed with stages I, II and III cervical cancer are treated with chemo-radiation (pelvic external-beam radiation, weekly cisplatin chemotherapy and HDR cervical brachytherapy). Patients are given anaesthesia during the inpatient brachytherapy procedure that lasts 1 day. In our institution, morphine is used as the intrathecal anaesthetic for pain relief in these patients. Patients who give informed consent will be recruited for this study. As per routine practice, spinal anaesthesia with intrathecal morphine will be given as analgesic for brachytherapy. Patients will be monitored for hemodynamic variables like Heart rate, Blood pressure, Oxygen saturation( SpO2 ) throughout the procedure and also in the recovery room. Patients will be assessed for i)Nausea and vomiting, ii)need for anti emetics, iii) pain score, iv)need for rescue analgesia,v)sedation score, vi)pruritus and respiratory depression in the recovery room as well as in the postoperative ward. Nausea and vomiting will be assessed by nausea vomiting score (0 = No nausea , 1 = Nausea, 2 = Retching, 3=Vomiting) Pain will be assessed by visual analogue scale ( VAS : 0 to 10 scale in which 0 = no pain, 10 = maximum pain). Sedation will be assessed by Ramsay sedation score (RSS: 1=Anxious, agitated, restless, 2= Co operative, oriented, tranquil, 3=Responds to command only, 4 = Asleep, brisk response to stimulus,5 = Asleep, sluggish response to stimulus, 6 = Un arousable). A respiratory rate of < 8 breaths/minute and oxygen saturation of <92% will be taken as respiratory depression The total dose of opioids administered, the first time of rescue analgesic administered, antiemetics given will be noted and analysed. The study hypothesis is that intrathecal morphine is a good analgesic with no side effects in patients undergoing Brachytherapy. |