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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.
 
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