| CTRI Number |
CTRI/2024/10/075141 [Registered on: 11/10/2024] Trial Registered Prospectively |
| Last Modified On: |
02/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparing Dexmedetomidine to a standard treatment to see if it helps reduce confusion in elderly undergoing urological surgeries under spinal anesthesia |
|
Scientific Title of Study
|
Effect of Intravenous Sedation with Dexmedetomidine on Postoperative Delirium in Elderly undergoing Endoscopic Urological Surgeries under Spinal Anesthesia – A Randomized 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 Nada Fathima |
| Designation |
Junior Resident |
| Affiliation |
JIPMER |
| Address |
Department of Anesthesiology and Critical Care
2nd Floor IPD block
JIPMER
Pondicherry
Pondicherry PONDICHERRY 605006 India |
| Phone |
8590554401 |
| Fax |
|
| Email |
nadafathima04@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Gnanasekaran S |
| Designation |
Associate Professor |
| Affiliation |
JIPMER |
| Address |
Department of Anesthesiology and Critical Care
2nd floor IPD block
JIPMER
Pondicherry
Pondicherry PONDICHERRY 605006 India |
| Phone |
9487188275 |
| Fax |
|
| Email |
gnansdr@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Nada Fathima |
| Designation |
Junior Resident |
| Affiliation |
JIPMER |
| Address |
Department of Anesthesiology and Critical Care
2nd Floor IPD block
JIPMER
Pondicherry
Pondicherry PONDICHERRY 605006 India |
| Phone |
8590554401 |
| Fax |
|
| Email |
nadafathima04@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER)
Dhanvantri Nagar
Gorimedu
Pondicherry 605006
India
|
|
|
Primary Sponsor
|
| Name |
Dr Nada Fathima |
| Address |
Junior Resident
Department of Anesthesiology and Critical Care
Anesthesia Office
2nd Floor institute block
JIPMER
Pondicherry |
| 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 Nada Fathima |
Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER) |
Department of Anesthesiology and Critical Care
Anesthesia Office
2nd Floor Institute block
JIPMER
Dhanvantri Nagar
Gorimedu
Pondicherry
605006 Pondicherry PONDICHERRY |
8590554401
nadafathima04@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Interventional Studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: N401||Benign prostatic hyperplasia withlower urinary tract symptoms, (3) ICD-10 Condition: N20||Calculus of kidney and ureter, (4) ICD-10 Condition: C67||Malignant neoplasm of bladder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
Intravenous sedation with Dexmedetomidine infusion at 0.2-0.4mcg/kg/hour.
Infusion will be started after ensuring adequate level of blockade (at least T10) and hemodynamic stability following spinal anesthesia.
Infusion will be stopped at the end of surgery. |
| Comparator Agent |
Normal saline |
Intravenous infusion of 0.9% normal saline.
Infusion will be started after ensuring adequate level of blockade (at least T10) and hemodynamic stability following spinal anesthesia.
Infusion will be stopped at the end of surgery. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult patients aged 60 years or older undergoing endoscopic urological surgeries under spinal anesthesia.
2.American Society of Anesthesiologists (ASA) status 1 and 2.
|
|
| ExclusionCriteria |
| Details |
1.History of dementia or mini-cog less than 3.
2.History of psychiatric or neurodegenerative disorder
3.Profound hearing loss (difficulty in understanding loud speech)
4.Complete visual loss
5.Ischemic or valvular heart disease, heart failure (NYHA class 3 or 4), uncontrolled hypertension, severe pulmonary disease.
6.End Stage Renal Disease / Hepatic impairment.
7.Patients with failed spinal/high spinal
|
|
|
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 |
| Comparison of incidence of postoperative delirium based on Confusion Assessment Method (CAM-ICU) algorithm |
Postoperative period- At 24hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of incidence of postoperative delirium based on Confusion Assessment Method (CAM-ICU) algorithm |
48 and 72 hours in the postoperative period |
| Mean Arterial Pressure (MAP) and heart rate |
Intraoperative- baseline, start of infusion and every 15 minutes
Postoperative for 24 hours (every 6 hours) |
| VAS score |
2,6,12, and 24 hours in the postoperative period |
| Catheter-induced bladder discomfort intensity by a 3point likert scale (1-comfortable, 2-uncomfortable but bearable, 3-uncomfortable and unbearable) |
2,6,12, and 24 hours in the postoperative period |
| Side effect profile (hypotension, bradycardia, desaturation, oversedation) |
Intraoperative and postoperative
period |
| Number of boluses of mephentermine administered |
Intraoperative period |
| Length of hospital stay in days after surgery |
Date of surgery to date of discharge |
|
|
Target Sample Size
|
Total Sample Size="116" Sample Size from India="116"
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)
|
21/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
21/10/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" 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
|
Postoperative delirium is a common complication seen during the
postoperative course especially in elderly and has a deep impact on the
healthcare of patients and thus on the healthcare financial management. Incidence
of Postoperative Delirium (POD) is
7.8- 21.23% in endoscopic urological studies. Various studies have
been demonstrated a reduced incidence of postoperative delirium with
dexmedetomidine in cardiac and non-cardiac surgeries like orthopedic, abdominal and spine surgeries etc. Its impact in patients undergoing
endoscopic urological surgeries is unexplored. We
expect that the usage of dexmedetomidine sedation in elderly patients
undergoing endoscopic urological surgeries will reduce the incidence of postoperative
delirium.METHODOLOGYPatients satisfying the inclusion criteria will be included in the study after obtaining informed written consent. Baseline cognition status will be evaluated using the Mini-cog tool on the previous
day. On arrival to the OR, standard ASA monitors [pulse oximeter, non-invasive
blood pressure (NIBP), electrocardiography (ECG)] will be attached. Intravenous
access will be secured, and the patient will
be positioned in lateral decubitus for spinal anesthesia. Under sterile aseptic
precautions, the subarachnoid blockade will be
administered at L3/4 0r L4/5 with a 25-gauge Quincke needle in the lateral
decubitus position. After confirmation of free flow of clear cerebrospinal
fluid, 10-15mg of 0.5% hyperbaric bupivacaine will
be administered intrathecally. The patient will be turned to supine position
and a forced air warming blanket will be applied to the upper body to maintain
normothermia. After ensuring adequate
level of blockade (at least T10) and hemodynamic stability, study participants
will be randomly divided into two groups: Group D and Group C. Entropy sensors
will be attached to patients prior to start of drug infusion. Study participants in Group D will receive Dexmedetomidine
infusion at 0.2-0.4mcg/kg/hr. and those in Group C will receive 0.9% Normal
Saline infusion at the same rate. Drug infusion will be titrated to maintain
entropy between 60-80. Modified observer’s assessment
of alertness/sedation (OAA/S) score will noted at every 15 minutes. All
patients will receive supplemental oxygen via nasal prongs (3L O2). Study drug infusion will be stopped at the end of surgery.
Vital parameters including blood pressure, heart rate and oxygen saturation
will be monitored at baseline (before administration of spinal), start
of infusion and throughout the surgery. Side
effects such as hypotension, bradycardia, desaturation and oversedation will be
noted. Patients who develop hypotension (systolic blood pressure less than 20%
from the baseline or less than 90 mmHg) will be treated with an intravenous 3
mg bolus dose of mephentermine and the number of boluses will be noted. When
the heart rate (HR) falls to less than 45 beats/min and is associated with
hypotension, atropine (0.6 mg) will be administered. The
patient will be shifted to PACU and will be monitored in PACU for 2hours and then shifted to ward. Vital parameters will be monitored
every 6 hours for 24 hours. The confusion assessment
method (CAM-ICU) will be used to determine the occurrence of postoperative
delirium at 24, 48 and 72 hours. Psychiatric
consultations will be scheduled for patients who develop delirium to ensure
they receive the appropriate treatment. All patients will receive intravenous
paracetamol 15mg/kg q8h and pain will be assessed using VAS score at 2, 6, 12, and 24 hours. In patients with a VAS score of more than 5, a bolus of 25mg tramadol IV will be given. Catheter-induced
bladder discomfort intensity will be assessed at using a 3-point scoring system
(1-comfortable, 2-uncomfortable but bearable, 3-uncomfortable, and unbearable)12
at 2, 6, 12, and 24 hours and the urologist
will be informed if it is grade 3.
|