| CTRI Number |
CTRI/2025/08/092522 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
06/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing efficacy of oral Gabapentin and oral Clonidine as premedication on reducing postoperative pain,nausea
and vomiting after general anaesthesia in Mastoidectomy surgery |
|
Scientific Title of Study
|
Comparing effectiveness of oral Gabapentin Versus oral Clonidine as premedication on Postoperative Pain Intensity Levels and incidence of Nausea
and Vomiting after General Anaesthesia in Mastoidectomy surgery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IEC/2024/2/42 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vimal M |
| Designation |
MD Postgraduate in Anaesthesiology |
| Affiliation |
ESIC Medical College |
| Address |
Department of Anaesthesiology,ESIC Medical Colege,KK Nagar,Chennai
Chennai
TAMIL NADU
600078
India |
| Phone |
8754965235 |
| Fax |
|
| Email |
m.vimal.1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Radhika K |
| Designation |
Professor in Anaesthesiology |
| Affiliation |
ESIC Medical College |
| Address |
Department of Anaesthesiology,ESIC Medical College,KK Nagar,Chennai
Chennai
TAMIL NADU
600078
India |
| Phone |
9840170887 |
| Fax |
|
| Email |
radhikamurali0095@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vimal M |
| Designation |
MD Postgraduate in Anaesthesiology |
| Affiliation |
ESIC Medical College |
| Address |
Department of Anaesthesiolgy,ESIC Medical College,KK Nagar,Chennai
Chennai
TAMIL NADU
600078
India |
| Phone |
8754965235 |
| Fax |
|
| Email |
m.vimal.1998@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESIC Medical College & Hospitals,KK nagar,Chennai,Tamil Nadu,INDIA-600078 |
|
|
Primary Sponsor
|
| Name |
Dr Vimal M |
| Address |
Dept. of Anaesthesiology,ESIC Medical College & Hospital,KK NAGAR,CHENNAI-600078 |
| 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 Vimal M |
ESIC Medical College and Hospital |
Department of Anaesthesiology,ESIC Medical College,KK Nagar,Chennai-600078
Chennai
TAMIL NADU |
8754965235
m.vimal.1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ESIC Medical College & Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H60-H95||Diseases of the ear and mastoid process, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CLONIDINE |
The alpha-agonist clonidine has also shown properties that are potentially beneficial for premedication to reduce sympathetic activity, the incidence of shivering and oxygen consumption during recovery from anaesthesia, to decrease anaesthetic and analgesic requirement and minimize postoperative pain, nausea and vomiting (Ghignone et al., 1987; Quintin et al., 1991).
In the study by Pandey et al. (2006) on two hundred and fifty patients scheduled for
laparoscopic Cholecystectomy, gabapentin as premedication effectively suppresses nausea
and vomiting and post-operative rescue analgesic requirement (Pandey et al., 2006).
Therefore we conducted a study to compare the effects of 300 mg oral gabapentin doses with 0.2 mg clonidine as premedication; on Postoperative Pain Intensity Levels, incidence of nausea and vomiting in patients undergoing elective mastoidectomy surgery under general anaesthesia. |
| Intervention |
GABAPENTIN |
Gabapentin is an anticonvulsant that has antinociceptive properties. It binds the alpha 8 subunits of voltage dependent calcium ion channels and blocks the development of hyperalgesia and central sensitization (Rose and Kam, 2002).MOA.
After a single oral dose of 300 mg gabapentin, mean maximum plasma concentrations attained in 2-3 h. Bio-availability of a single 300 mg oral dose of gabapentin is 60% . Elimination of gabapentin is by renal clearance and is about 5-7 h after a single oral dose of 200 to 400m g(Goa and Sorkin, 1993).
clinical study demonstrated the anti-emetic effect of gabapentin in chemotherapy-induced acute (within 24 h) and delayed onset (days 2-5) of nausea and vomiting; Mitigation of tachykinin neurotransmitter activity by gabapentin has been postulated to play a role (Guttuso et al., 2003). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patient posted for Mastoidectomy surgery
2)18-60 years of age
3)ASA physical status 1&2 |
|
| ExclusionCriteria |
| Details |
1)Known allergy to gabapentin and clonidine
2)Patient refusal
3)Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the post operative pain intensity levels between the oral clonidine and oral gabapentin groups |
First 12 hours postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the incidence of postoperative nausea & vomiting between the two groups |
First 12 hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
20/08/2025 |
| 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="1"
Months="0"
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
|
To assess the efficacy of oral gabapentin versus oral clonidine on reducing the postoperative pain intensity level and the incidence of nausea and vomiting, when given as oral premedication in patients undergoing Mastoidectomy surgery under general anaesthesia |