| CTRI Number |
CTRI/2024/04/066381 [Registered on: 26/04/2024] Trial Registered Prospectively |
| Last Modified On: |
25/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Inj.Dexmedetomidine and Inj. Fentanyl for prevention of post-operative agitation in patients who underwent Laparoscopic surgery under inhalation agent-Sevoflurane |
|
Scientific Title of Study
|
Comparison of Dexmedetomidine and Fentanyl for prevention of emergence agitation in adult patients after laparoscopic surgeries under Sevoflurane anaesthesia. A randomised double blinded study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Phalguni |
| Designation |
Resident Doctor |
| Affiliation |
Government Medical College, Vadodara |
| Address |
Department of Anesthesiology
New surgical block
SSG Hospital
Vadodara
Vadodara
GUJARAT
390001
India |
| Phone |
9918528970 |
| Fax |
|
| Email |
phalgunisrivastava@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamta Patel |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College, Vadodara |
| Address |
Department of Anesthesiology
New surgical block
SSG Hospital
Vadodara
Vadodara
GUJARAT
390001
India |
| Phone |
9825453024 |
| Fax |
|
| Email |
mgpatel111@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mamta Patel |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College, Vadodara |
| Address |
Department of Anesthesiology
New surgical block
SSG Hospital
Vadodara
Vadodara
GUJARAT
390001
India |
| Phone |
9825453024 |
| Fax |
|
| Email |
mgpatel111@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology,
SSG Hospital,
Vadodara |
|
|
Primary Sponsor
|
| Name |
Governement Medical College, Vadodara |
| Address |
Department of Anesthesiology,
SSG Hospital,
Vadodara |
| Type of Sponsor |
Government medical college |
|
|
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 Phalguni |
SSG Hospital |
Operation Theater
2nd floor
New surgical block
SSG Hospital
Vadodara
Vadodara
GUJARAT |
9918528970
phalgunisrivastava@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Biomedical and Health Research (IECHBR), Medical college, SSG Hospital, Baroda |
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 |
| Comparator Agent |
Inj. Dexmedetomidine |
In this group patients will be given Inj. Dexmedetomidine in the dose of 1 mcg/kg IV. 1 ml of Inj. Dexmedetomidine will be taken and diluted till 10 ml to prepare a concentration of 10 mcg/ ml. This will be given during induction of anesthesia
|
| Comparator Agent |
Inj. Fentanyl |
In this group, patients will be given Inj. Fentanyl in the dose of 1 mcg/kg IV. Here, 2 ml of the drug will be taken and diluted till 10 ml to prepare a concentration of 10 mcg/ml. This will be given during induction of anesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing elective laparoscopic surgery.
2. Patients conformed to American Society of Anaesthesiologists (ASA) physical status I-II in preoperative assessment
|
|
| ExclusionCriteria |
| Details |
1. Inability or refusal to follow the study protocol.
2. Patients with mental retardation, history of agitation, coagulation disorder, dementia, cerebral insult, intracranial surgery.
3. Patients with known allergy to the study drugs.
|
|
|
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 |
| To determine the effectiveness in prevention of emergence agitation, using the drugs Inj. Dexmedetomidine and Inj. Fentanyl in patients undergoing laparoscopic surgeries after Sevoflurane Anaesthesia. |
Emergence time will be noted. Emergence time is the time from discontinuation of anaesthetics to extubation.
Incidence of Agitation will be noted,
Agitation score using the Riker sedation agitation score will be noted.
This will be noted upto 24 hours post-operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To determine incidence of emergence agitation for 24 hours post operatively after using Sevoflurane during laparoscopic surgeries.
2. To compare hemodynamic stability in patients given Inj. Dexmedetomidine or Inj. Fentanyl undergoing laparoscopic surgeries under general anaesthesia with Sevoflurane.
3. To monitor any complications like Bradycardia, hypotension, respiratory depression with the use of Inj. Dexmedetomidine or Inj. Fentanyl in laparoscopic surgeries.
|
Intraoperatively:Blood pressure, Heart rate, SpO2, & ET-CO2 will be recorded just before drug administration(T0), just after drug administration(T1),then 5, 10, 15 minutes(T2, T3, T4) after induction then every 30 minutes after the induction (T5,T6,T7), & at the end of the surgery(T8).
Post-operatively-Patient’s Blood pressure, pulse rate, SpO2 & agitation will be noted till 24 hours. Initially every 10 minutes for 1 hour & then hourly till 4 hours & then 4 hourly till 24 hours. |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
08/05/2024 |
| 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 randomized double-blind study to compare the effectiveness of Inj. Dexmedetomidine and Inj. Fentanyl in the prevention of emergence agitation in adult patients undergoing laparoscopic surgeries under Sevoflurane Anesthesia. Problems of post-anesthesia emergence have been shown to occur in 5–10% of general surgery patients of all ages. Inhalation anesthetics, especially Sevoflurane, are also a potential risk factor for emergence agitation. Various medications have been used for the prevention of emergence agitation after general anesthesia which includes ketamine, propofol, opioids, and Dexmedetomidine. Here, is the comparison of Dexmedetomidine with Fentanyl. Randomization: Patients will be randomly divided into two groups pre-operatively using computer-generated randomization.(www.randomiser.org) Group (D): (n=36) In this group patients will be given Inj. Dexmedetomidine in the dose of 1 mcg/kg IV. 1 ml of Inj. Dexmedetomidine will be taken and diluted to 10 ml to prepare a concentration of 10 mcg/ ml Group (F): (n=36) In this group, patients will be given Inj. Fentanyl in the dose of 1 mcg/kg IV. Here, 2 ml of the drug will be taken and diluted to 10 ml to prepare a concentration of 10 mcg/ml. MONITORING OF PARAMETERS: Intraoperatively: o Blood pressure, Heart rate, SpO2, and ET-CO2 will be recorded just before Inj. Dexmedetomidine or Inj. Fentanyl administration(T0), just after administering Inj. Dexmedetomidine or Inj. Fentanyl loading dose administration(T1), 5, 10, 15 minutes(T2, T3, T4) after induction then every 30 minutes after the induction (T5,T6,T7), and at the end of the surgery(T8). o Emergence time will be noted. Emergence time is the time from discontinuation of anesthetics to extubation. (TE) Postoperatively: Patient’s Blood pressure, pulse rate, SpO2, and agitation will be noted till 24 hours post-extubation. Initially every 10 minutes for 1 hour and then hourly till 4 hours post-extubation and then 4 hourly till 24 hours postextubation. The incidence of Agitation will be noted. Agitation score using the Riker sedation agitation score will be noted. | |