| CTRI Number |
CTRI/2023/08/055943 [Registered on: 01/08/2023] Trial Registered Prospectively |
| Last Modified On: |
21/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Cardiac autonomic dysfunction in
diabetic patients undergoing major surgeries |
|
Scientific Title of Study
|
Prevalence of cardiac autonomic neuropathy and its effect on perioperative haemodynamic parameters in diabetic patients undergoing major elective surgeries: A prospective observational study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anjum Naz |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Kalyani |
| Address |
AIIMS Kalyani,
Basantpur, Saguna, Nadia
Nadia
WEST BENGAL
741245
India |
| Phone |
9836893073 |
| Fax |
|
| Email |
dranjumnaz75@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anjum Naz |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Kalyani |
| Address |
AIIMS Kalyani,
Basantpur, Saguna, Nadia
WEST BENGAL
741245
India |
| Phone |
9836893073 |
| Fax |
|
| Email |
dranjumnaz75@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anjum Naz |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Kalyani |
| Address |
AIIMS Kalyani,
Basantpur, Saguna, Nadia
WEST BENGAL
741245
India |
| Phone |
9836893073 |
| Fax |
|
| Email |
dranjumnaz75@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Kalyani, Basantpur, Saguna, Nadia Distt, West Bengal.
|
|
|
Primary Sponsor
|
| Name |
AIIMS Kalyani |
| Address |
Basantpur, Saguna, Klayani,
West Bengal,
India |
| 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 |
| Anjum Naz |
AIIMS Klayani |
Department of Anaesthesiology, AIIMS Kalyani, Basantpur, Saguna, Klayani
Nadia
WEST BENGAL |
9836893073
dranjumnaz75@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee, AIIMS Kalyani |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E088||Diabetes mellitus due to underlying condition with unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult Diabetic patients scheduled for major elective surgeries. |
|
| ExclusionCriteria |
| Details |
Cardiac rhythm other than sinus rhythm, Parkinson’s disease, idiopathic orthostatic hypotension, Shy-Drager syndrome, Addison’s disease and hypopituitarism, pheochromocytoma, peripheral autonomic neuropathy, cardiomyopathy, and proven or suspected allergy for any of the medication used during induction of anaesthesia. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Prevalence of cardiac autonomic dysfunction in patients coming to Pre anaesthesia clinic with known or newly diagnosed diabetes mellitus |
1. Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Hemodynamic response to induction of anaesthesia, laryngoscopy, intubation, extubation in patients with Cardiac autonomic dysfunction
(CAN).
2. Incidence, duration & severity of intraoperative hypotension & hypertension & requirement of pharmacological intervention in patients with CAN. Severe hypotension will defined as a mean arterial pressure (MAP) of less than 50 mmHg or a 30 percent decrease in MAP from baseline. Severe hypertension will defined as a mean arterial pressure (MAP) of more than 50 mmHg or a 30 percent increase in MAP from baseline
3. Major Adverse Cardiac Events new onset myocardial ischemia, congestive cardiac failure, cardiac arrhythmias, cardiac arrest requiring resuscitation in patients with CAN.
4. Duration of hospital stay & in hospital motality
6. Ultrasound assessment of gastric content & volume. |
During surgery.
After surgery till the patient is discharged
|
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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)
|
01/08/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/08/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Cardiac autonomic neuropathy (CAN) is a serious complication among
diabetic patients. It occurs in both type 1 and type 2 diabetes, and its
progression results in poor prognosis and increased mortality. During its
course, parasympathetic and sympathetic nerve fibres of the cardiovascular system
are damaged, resulting in potentially serious cardiac complications and even
death. Poor glycaemic control and long duration of disease play an important
role in the pathogenesis of the autonomic disturbances associated with diabetes
mellitus. An
estimated 25% of diabetic patients will require surgery and associated cardiac
autonomic dysfunction can be a reason for significant perioperative morbidity. It
has been shown that diabetic patients with autonomic neuropathy are prone to
develop more cardiovascular events, including bradycardia, hypotension and
cardiopulmonary arrest during induction of anaesthesia and in the perioperative
period, compared with non-diabetic subjects.
Autonomic nervous
system (ANS), plays a central role in the regulation of multiple core
biological processes and its dysfunction can be a strong reason of development
of serious postoperative morbidity which can lead to a prolonged hospital stay.
Screening of CAN
preoperatively may be helpful to improve the management of diabetic surgical
patients requiring general or regional anaesthesia. There are some studies
which have evaluated the prevalence of cardiac autonomic dysfunction and its
anaesthetic implications, however, there is paucity of studies done in Indian
population and it is important to collect patient response data from several
regions, both within the country and worldwide. We are planning to conduct this
observational study to evaluate the prevalence of cardiac autonomic dysfunction
in patients of Eastern India with diabetes mellitus who will present at our
hospital for major elective surgeries. We also plan to study the haemodynamic effects
of CAN in the perioperative period, postoperative morbidity and length of
hospital stay.
Study
Design
Study type:
Observational
Observational model: Cohort
Time perspective: Prospective
Intervention: No
intervention
|