| CTRI Number |
CTRI/2024/06/069399 [Registered on: 24/06/2024] Trial Registered Prospectively |
| Last Modified On: |
10/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of three anaesthesia medication combinations given through the epidural route (in the space surrounding the spinal cord) regarding their ability to influence blood pressure during surgery in patients undergoing open surgery for ovarian cancer. |
|
Scientific Title of Study
|
Intra-operative hypotension with three different epidural regimens in patients undergoing laparotomy for Carcinoma Ovary- a pilot study for a randomised controlled trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nairita Das |
| Designation |
Assistant Professor |
| Affiliation |
Cancer Institute (WIA) Adyar, Chennai |
| Address |
Department of Anaesthesia,Pain and Palliative Care,
Cancer Institute(WIA),
38, Sardar Patel Road,Adyar
Chennai
Chennai
TAMIL NADU
600036
India |
| Phone |
9940656437 |
| Fax |
|
| Email |
nairita1987@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nairita Das |
| Designation |
Assistant Professor |
| Affiliation |
Cancer Institute (WIA) Adyar, Chennai |
| Address |
Department of Anaesthesia,Pain and Palliative Care,
Cancer Institute(WIA),
38, Sardar Patel Road,Adyar
Chennai
Chennai
TAMIL NADU
600036
India |
| Phone |
9940656437 |
| Fax |
|
| Email |
nairita1987@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aravind Narayanan |
| Designation |
Associate Professor |
| Affiliation |
Cancer Institute (WIA) Adyar, Chennai |
| Address |
Department of Anaesthesia,Pain and Palliative Care,
Cancer Institute(WIA),
38, Sardar Patel Road,Adyar
Chennai
Chennai
TAMIL NADU
600036
India |
| Phone |
8056220800 |
| Fax |
|
| Email |
dr.aravindn@gmail.com |
|
|
Source of Monetary or Material Support
|
| Cancer Institute (WIA) Adyar, Chennai,Tamilnadu, India, 600036 |
|
|
Primary Sponsor
|
| Name |
Dr Nairita Das |
| Address |
Department of Anaesthesia,Pain and Palliative Care,
Cancer Institute(WIA),
38, Sardar Patel Road,Adyar
Chennai, Tamilnadu, India, 600036 |
| Type of Sponsor |
Other [Self] |
|
|
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 Nairita Das |
Cancer Institute (WIA) Adyar, Chennai |
Department of Anaesthesia,Pain and Palliative Care,
Cancer Institute(WIA),
38, Sardar Patel Road,Adyar
Chennai
Chennai
TAMIL NADU |
9940656437
nairita1987@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Cancer Institute(WIA) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bupivacaine |
Epidural Bupivacaine infusion 0.1% at 4 ml/hr plus single epidural normal saline 3 ml bolus from laparotomy incision till end of surgery |
| Intervention |
Bupivacaine,Morphine |
Epidural Bupivacaine infusion 0.1% at 4ml/hour plus single epidural morphine bolus 50mcg/kg ideal body weight from laparotomy incision till end of surgery |
| Comparator Agent |
Morphine |
Epidural normal saline infusion 4ml/hour plus single epidural morphine bolus 50mcg/kg ideal body weight from laparotomy incision till end of surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
1)Age greater than 18 years 2)Carcinoma Ovary patients posted for elective open staging laparotomy 3)ASA (American Society of Anaesthesiologists) physical status 1,2 and 3 patients.
|
|
| ExclusionCriteria |
| Details |
1.Patients not consenting/contraindication to epidural.
2.ASA4 and above patients.
3.Low preoperative BP (systolic BP less than 100mmHg) either during pre-medication visit or the baseline vitals on shifting to operating theatre.
4.Patients with low ejection fraction (less than 50%) and/or regional wall motion abnormalities.
5.Patients declared inoperable after diagnostic laparoscopy.
6.Patients with allergy to any of the study drugs
7.Patients with severe or massive ascitis or in obstruction.
8.Patients with a low preoperative BMI less than 18.5 kg/m2.
9.Patients with marked hypoalbuminemia (Serum albumin less than 2.5 g/dL)
10. Any emergency surgeries.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Number of episodes of intraoperative hypotension (defined as mean arterial blood pressure less than 70 mmHg) from the time of laparotomy incision to two hours from laparotomy incision.
2. Mean of the mean arterial blood pressure (in mmHg) during these intra-operative hypotension episodes from laparotomy incision to two hours from laparotomy incision.
|
Starting point of measurement: Time of laparotomy incision
End point of measurement: two hours from the point of laparotomy incision |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total dose of ephedrine in milligrams and/or phenylephrine in micrograms to treat this Intraoperative hypotension |
From laparotomy incision to two hours from laparotomy incision.
|
| Maximum dose of noradrenaline requirement in mcg/kg/min to treat Intraoperative hypotension and duration of Noradrenaline requirement. |
From laparotomy incision to two hours from laparotomy incision.
|
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
24/06/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomised controlled, double blinded, parallel group, single centre study to compare three different intra-operative epidural regimens and investigate their propensity to cause intra-operative hypotension as defined by a mean arterial blood pressure less than 70 mmHg. The three epidural regimens are only bupivacaine, only morphine or both. The primary outcome is the number of episodes of intraoperative hypotension and the mean of the mean arterial blood pressure of these episodes. The secondary outcomes are the ephedrine and/or phenylephrine requirement, maximum noradrenaline requirement and duration of noradrenaline requirement and fluid requirements. All measurements will be done from the time of administration of the study drug which is at laparotomy incision to two hours from then. The hypothesis is that the combination of epidural bupivacaine and morphine is likely to cause more hypotension than the comparators. |