| CTRI Number |
CTRI/2018/04/013177 [Registered on: 11/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
25/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of the effects of adding drug fentanyl via two different routes in patients undergoing cataract surgeries. |
|
Scientific Title of Study
|
Comparative evaluation of perioperative outcomes of peribulbar fentanyl versus intravenous fentanyl in cataract surgeries under monitored anaesthesia care. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Netakani Navajeevan |
| Designation |
Primary DNB in Anaesthesiology |
| Affiliation |
Bhagat Phool Singh Government Medical College for Women |
| Address |
Operation theatre complex, Department of anaesthesiology, Bhagat Phool Singh Government Medical College for Women, Khanpur Kalan, Sonepat.
Sonipat
HARYANA
Netakani Navajeevan
India |
| Phone |
9728223941 |
| Fax |
|
| Email |
nanixmen@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Meenu Agrawal |
| Designation |
ASSOCIATE PROFESSOR, MBBS, MD (ANAESTHESIA) |
| Affiliation |
Bhagat Phool Singh Government Medical College for Women, Khanpur Kalan, Sonepat, Haryana. |
| Address |
Operation theatre complex, Department of Anaesthesia, Bhagat Phool Singh Government Medical College for Women, Khanpur Kalan, Sonepat, Haryana.
29-A, sujan singh park, near gurudwara, old D.C Road, sonepat, Haryana.
Sonipat
HARYANA
131305
India |
| Phone |
9467823780 |
| Fax |
|
| Email |
meenu297@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Meenu Agrawal |
| Designation |
ASSOCIATE PROFESSOR, MBBS, MD (ANAESTHESIA) |
| Affiliation |
Bhagat Phool Singh Government Medical College for Women, Khanpur Kalan, Sonepat, Haryana. |
| Address |
Operation theatre complex, Department of Anaesthesia, Bhagat Phool Singh Government Medical College for Women, Khanpur Kalan, Sonepat, Haryana.
29-A, sujan singh park, near gurudwara, old D.C Road, sonepat, Haryana.
Jind
HARYANA
131305
India |
| Phone |
9467823780 |
| Fax |
|
| Email |
meenu297@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Bhagat Phool Singh Government Medical College for Women, Khanpur Kalan, Sonepat, Haryana. |
|
|
Primary Sponsor
|
| Name |
Bhagat Phool Singh Government Medical College for Women |
| Address |
Bhagat Phool Singh Government Medical College for Women, Khanpur Kalan, Sonepat, Haryana. |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not applicable |
Not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Netakani Navajeevan |
Operation theatre complex, Department of Anaesthesiology |
Bhagat Phool Singh Government Medical College for Women, Khanpur Kalan, Sonepat, Haryana.
Sonipat
HARYANA |
9728223941
nanixmen@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA grade I/II/III patients posted for elective cataract surgeries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparison between intravenous and peribulbar fentanyl in cataract surgeries. |
The patients will be divided into two groups:-
1. Group A: Peribulbar fentanyl group (25µg).
2. Group B: Intravenous fentanyl group (1µg/kg I.V diluted upto 10ml in normal saline).
|
| Intervention |
Comparison between two routes of fentanyl in cataract surgeries. |
The patients will be divided into two groups:-
1. Group A: Peribulbar fentanyl group (25µg).
2. Group B: Intravenous fentanyl group (1µg/kg I.V diluted upto 10ml in normal saline).
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. American society of anaesthesiologists (ASA) grade I to III patients.
2. Patients in the age group of 40-80 years will be included in the study.
3. Patients of all genders.
4. Patients who are willing to provide their voluntary written informed consent for participation in the study.
|
|
| ExclusionCriteria |
| Details |
1. Patients who are not willing to give their consent for participation in the present study.
2. History of allergy to the drug under study or local anaesthetics used.
3. Patients who have known coagulation abnormalities, patients with impaired orbital and periorbital sensation, disturbed conscious level, active respiratory disease, poor communication ability as deafness and patients with excessive tremors or agitations.
4. Patients with abnormal ocular conditions as vitreous haemorrhage, posterior staphyloma and glaucoma.
5. Patients previously on treatment with chronic analgesics and antipsychotic drugs.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Analgesic efficacy of fentanyl and duration of analgesia by different routes. |
From the time of administration of fentanyl to maximum of 24 hours postoperatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Side effects and patient and surgeon satisfaction scores. |
From the time of administration of fentanyl to maximum of 24 hours postoperatively. |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
05/02/2018 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Regional anaesthesia has gained popularity over
general anaesthesia owing to lesser complications, better post-operative
analgesia and better patient compliance due to faster recovery. Cataract
surgeries are generally performed under regional anaesthesia (peribulbar block)
due to short duration of surgery and ease of administration. Several drugs have
been added as adjuvants to local anaesthetic used in peribulbar block in order
to achieve faster onset of lid and globe akinesia (to start the surgery), to
prolong the duration of postoperative analgesia and to minimise the analgesic
requirement. In our study, we aim to compare the effect of adding fentanyl as
adjuvant to local anaesthetic solution via two routes, i.e., peribulbar and
intravenous. A total of 160 patients will be randomly divided into 2 groups
with 80 patients in each group. Group A patients will receive 25µg of fentanyl
diluted up to 1ml in normal saline along with peribulbar block and group B
patients will receive intravenous fentanyl (1µg/kg) diluted up to 10ml in
normal saline prior to peribulbar block. Peri-operatively, all the patients
will be monitored for vitals such as blood pressure, pulse, respiratory rate,
spo2 and ECG. Duration of analgesia, time for rescue analgesic and number of
analgesic doses needed to relieve the pain will be recorded in both groups
postoperatively upto 24 hours. Thereafter, comparisons will be made among the two
groups based on the data collected. The different variables and occurrence of
side effects, if any, would also be noted and compared amongst both groups. The
anticipated outcome of the study will be in terms of duration of analgesia by
different routes and patient and surgeon satisfaction satisfaction scores. |