| CTRI Number |
CTRI/2025/01/079737 [Registered on: 29/01/2025] Trial Registered Prospectively |
| Last Modified On: |
29/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia Preventive Other (Specify) [Different routes of drug administration] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the action of dexmedetomidine drug given through the nostrils vs blood on changes in heart rate and blood pressure during keyhole surgeries in adult patients. |
|
Scientific Title of Study
|
Comparison of effect of intravenous vs intranasal dexmedetomidine on stress response to pneumoperitoneum in adults undergoing laparoscopic surgery: a double blinded hospital based randomised clinical 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 |
VARSHA B SHETTY |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College, Belagavi |
| Address |
Department Of Anaethesiology, Jawaharlal Nehru Medical College, Nehru Nagar,
Belgaum
KARNATAKA
590010
India
Belgaum KARNATAKA 590010 India |
| Phone |
9663835852 |
| Fax |
|
| Email |
drvarshashetty94@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Vandana A Gogate |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College, Belagavi |
| Address |
Department Of Anaethesiology, Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi 590010
Belgaum
KARNATAKA
590010
India
Belgaum KARNATAKA 590010 India |
| Phone |
9844083030 |
| Fax |
|
| Email |
vandanagogate@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
VARSHA B SHETTY |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College, Belagavi |
| Address |
Department Of Anaethesiology, Jawaharlal Nehru Medical College, Nehru Nagar,
Belgaum
KARNATAKA
590010
India
Belgaum KARNATAKA 590010 India |
| Phone |
9663835852 |
| Fax |
|
| Email |
drvarshashetty94@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi,Karnataka, India, 590010 |
|
|
Primary Sponsor
|
| Name |
Varsha B Shetty |
| Address |
Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi, Karnataka, India-590010 |
| 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 Varsha B Shetty |
Jawaharlal Nehru Medical College, Belagavi |
2nd Floor, Department of Anaesthesiology, JNMC, Nehru Nagar, Belagavi, Karnataka-10
Belgaum
KARNATAKA Belgaum KARNATAKA |
9663835852
drvarshashetty94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics Committee, Jawaharlal Nehru medical college, Belagavi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
INTRANASAL DEXMEDETOMIDINE |
After obtaining the approval of ethical committee, written informed consent will be taken from patients meeting the inclusion criteria after pre anaesthetic evaluation. Patients will be randomized based on computer generated randomization table into two groups of 32 each(Total 64). 10 minutes prior to shifting to OT, GROUP 1 will receive 1.5 mcg/kg of intranasal dexmedetomidine in undiluted form, prepared from parenteral preparation (100 µg/ml) using an atomizer(stat dose), equal volume to both nostrils in supine head down position while GROUP 2 will receive equivalent volume of distilled water intranasally (stat). Sedation status noted using Ramsay Sedation Scale in preoperative area. All patients to be induced with IV Inj. propofol 2mg/kg and IV succinylcholine 2mg/kg to facilitate tracheal intubation. Anaesthesia will be maintained with 50% O2-N2O mixture, isoflurane 1-1.2 MAC, loading dose of vecuronium 0.1mg/kg followed by top ups of 1/4th the loading dose. Hemodynamic parameters (MAP, SBP, DBP and HR) to be recorded at BASELINE(PRE-OP),5mins before insertion of ports(T0),at the time of insufflation of abdomen(TP) and then every 5 minutes for 30 minutes.(T5,T10,T15,T20,T25,T30). |
| Comparator Agent |
INTRVENOUS DEXMEDETOMIDINE |
GROUP 2 will receive 0.5 mcg/kg of intravenous dexmedetomidine in diluted form, prepared from parenteral preparation (100 µg/ml), Immediately after intubation over 10 minutes while GROUP 1 patients will receive equivalent volume of Normal Saline infusion. Sedation status noted using Ramsay Sedation Scale in the preoperative area. All patients to be induced and anaesthesia to be maintained similar to GROUP 1. Hemodynamic parameters (MAP, SBP, DBP and HR) to be recorded at BASELINE(PRE-OP),5mins before insertion of ports(T0),at the time of insufflation of abdomen(TP) and then every 5 minutes for 30 minutes.(T5,T10,T15,T20,T25,T30). In both groups, cardiovascular changes will be managed either by increasing the dose of isoflurane or giving IV fentanyl 0.5mcg/kg top up.
The anaesthesia personnel noting down the parameters would be blinded to the allotted group of the patient.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) ASA physical status 1 and II
2) Patients undergoing laparoscopic surgeries under general anaesthesia
3) Provides consent
|
|
| ExclusionCriteria |
| Details |
1) Patient refusal or unable to give consent
2) ASA physical status III & above
3)Patients with nasal deformities.
4)Patients allergic to study drug.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of intravenous vs intranasal dexmedetomidine on stress response to pneumoperitoneum in laparoscopic surgeries |
Baseline(Preop),5 mins before Pneumoperitoneum(T0),At the time of Pneumoperitoneum(TP),and then every 5mins thereafter[5mins (T5),10mins (T10),15mins (T15),20mins (T20),25mins (T25),30mins (T30)] |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the side effects of study drug if any. |
UPTO 6 HOURS POST OP. |
|
|
Target Sample Size
|
Total Sample Size="64" Sample Size from India="64"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
09/02/2025 |
| 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="2" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Laparoscopic surgeries have become popular due to several postoperative benefits allowing quicker recovery, less tissue damage, avoiding big surgical incision, shorter hospital stay with consequent reduction in health care cost. But anaesthetic management in these patients has become complicated due to cardiopulmonary changes occuring during laryngoscopy, intubation, pneumoperitoneum and patient position required for different laparascopic surgeries. Hence the postoperative benefits of laparoscopy should be balanced against the intra-operative risks. Various drug combinations have been used with variable success to attenuate the sympathetic responses like: deepening the level of anesthesia with higher concentration of inhalational and intravenous anaesthetics agents, high dose of opioids, antihypertensives and beta adrenergic blockers. Dexmedetomidine is an alpha 2 adrenergic agonist that is currently being widely used for titrating sedation. It has sedative and analgesic property without causing much respiratory depression. When used as an intravenous adjuvant, it attenuates stress response associated with laryngoscopy, intubation as well as for pneumoperitoneum in laparoscopic surgeries providing haemodynamic stability. However,
adverse haemodynamic complications like hypotension, bradycardia and even
cardiac arrest may have reduced the widespread use of intravenous
dexmedetomidine. Moreover, Delayed recovery with intravenous dexmedetomidine is
also documented due to its sedative effect. It has been suggested that
alternative routes other than rapid intravenous delivery may help to minimise
the adverse effects of Dexmedetomidine while maintaining the advantageous
effect of attenuating the stress response to pneumoperitoneum. Intranasal route is more convenient,
effective, reduces first pass metabolism and has a high rate of patient
acceptance.
After obtaining the approval
of ethical committee a total of 64 patients undergoing laparoscopic surgeries
under General Anaesthesia will be included in the study.
After
having met inclusion and exclusion criteria and having obtained informed
consent, patients will be randomized based on computer generated randomization
table into two groups (32 each).
GROUP 1: will receive 1.5 mcg/kg of
intranasal dexmedetomidine
GROUP 2: will receive 0.5 mcg/kg of intravenous dexmedetomidine Hemodynamic parameters will be monitored. Sedation status in both groups, will also be assessed using the Ramsay sedation scale (RSS) in the pre-operative area. All patients to be induced with IV Inj. propofol 2mg/kg and IV succinylcholine 2mg/kg to facilitate tracheal intubation. Anaesthesia will be maintained with 50% O2-N2O mixture, isoflurane 1-1.2 MAC, loading dose of vecuronium 0.1mg/kg followed by top ups of 1/4th the loading dose. Hemodynamic parameters (MAP, SBP, DBP and HR) will be recorded every 5 minutes. Hence, this study is planned to investigate the effect of intravenous vs intranasal dexmedetomidine on attenuation of hemodynamic changes that occur after creation of pneumoperitoneum in laparoscopic surgeries. |