| CTRI Number |
CTRI/2024/03/063398 [Registered on: 01/03/2024] Trial Registered Prospectively |
| Last Modified On: |
27/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy Of Prophylactic Intravenous Administration Of Ondansetron For Prevention Of Spinal Anaesthesia Induced Hypotension. |
|
Scientific Title of Study
|
A Comparative Study Of Prophylactic Intravenous Ondansetron On Spinal Anaesthesia Induced Hypotension Versus Placebo. |
| 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 Bandini Singhal |
| Designation |
Junior Resident 2 |
| Affiliation |
Government Medical College,Haldwani |
| Address |
Department of Anaesthesiology ,Critical care Pain and Palliative Medicine 2nd floor Dr Susheela Tiwari Hospital,Haldwani,Nainital,Uttarakhand
Nainital
UTTARANCHAL
263139
India |
| Phone |
9899930620 |
| Fax |
|
| Email |
bandini.singhal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Kumar Sinha |
| Designation |
Professor |
| Affiliation |
Government Medical College,Haldwani |
| Address |
Department of Anaesthesiology ,Critical care Pain and Palliative Medicine 2nd floor Dr Susheela Tiwari Hospital,Haldwani,Nainital,Uttarakhand
Nainital
UTTARANCHAL
263139
India |
| Phone |
9897672301 |
| Fax |
|
| Email |
sinhaak1961@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajay Kumar Sinha |
| Designation |
Professor |
| Affiliation |
Government Medical College,Haldwani |
| Address |
Department of Anaesthesiology ,Critical care Pain and Palliative Medicine 2nd floor Dr Susheela Tiwari Hospital,Haldwani,Nainital,Uttarakhand
Nainital
UTTARANCHAL
263139
India |
| Phone |
9897672301 |
| Fax |
|
| Email |
sinhaak1961@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Bandini Singhal Department of Anaesthesiology ,Critical care Pain and Palliative Medicine 2nd floor Dr Susheela Tiwari Hospital,Haldwani,Nainital,Uttarakhand 263139 |
|
|
Primary Sponsor
|
| Name |
Dr Bandini Singhal |
| Address |
Department of Anaesthesiology ,Critical care Pain and Palliative Medicine 2nd floor Dr Susheela Tiwari Hospital,Haldwani,Nainital,Uttarakhand |
| 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 Bandini Singhal |
Dr Susheela Tiwari Hospital |
Department of Anaesthesiology ,Critical care Pain and Palliative Medicine 2nd floor Dr Susheela Tiwari Hospital,Haldwani,Nainital,Uttarakhand
Nainital
UTTARANCHAL |
9899930620
bandini.singhal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,GMC,Haldwani |
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 |
INJECTION NORMAL SALINE(PLACEBO) |
The study population is divided into two groups of 38 each .Inj. ondansetron 4 mg diluted in 10 ml of NS for Group B while 10 ml of normal saline will be prepared for group A. Patient will be taken to the operating room and baseline noninvasive blood pressure (NIBP), heart rate (HR), and oxygen saturation (Spo2) will be recorded. Maintenance fluid (RL) will be started. Anesthesiologist blinded to the prepared drug solution slowly administered 10 ml solution over 10 seconds. After 5 minutes, spinal anaesthesia will be performed in L3-L4 interspace with 25 G Quincke’s spinal needle using 3.0 ml of 0.5% heavy bupivacaine in sitting position. Patient will be immediately placed in supine position. SBP, DBP, MAP, HR and oxygen saturation will be recorded in individual proforma at the time of spinal anaesthesia and then at an interval of three minutes up to 15 minutes and then every 5minutes.Patients developing the primary endpoint of hypotension (systolic blood pressure 20% in baseline values) will be treated with injection mephentermine 6 mg IV, and those developing bradycardia (heart rate less than 50bpm) will be treated with injection atropine 0.6mg IV. Surgery will be allowed to start once sensory and motor blockade is achieved. |
| Intervention |
INJECTION ONDANSETRON |
The study population is divided into two groups of 38 each .Inj. ondansetron 4 mg diluted in 10 ml of NS for Group B while 10 ml of normal saline will be prepared for group A. Patient will be taken to the operating room and baseline noninvasive blood pressure (NIBP), heart rate (HR), and oxygen saturation (Spo2) will be recorded. Maintenance fluid (RL) will be started. Anesthesiologist blinded to the prepared drug solution slowly administered 10 ml solution over 10 seconds. After 5 minutes, spinal anaesthesia will be performed in L3-L4 interspace with 25 G Quincke’s spinal needle using 3.0 ml of 0.5% heavy bupivacaine in sitting position. Patient will be immediately placed in supine position. SBP, DBP, MAP, HR and oxygen saturation will be recorded in individual proforma at the time of spinal anaesthesia and then at an interval of three minutes up to 15 minutes and then every 5minutes.Patients developing the primary endpoint of hypotension (systolic blood pressure 20% in baseline values) will be treated with injection mephentermine 6 mg IV, and those developing bradycardia (heart rate less than 50bpm) will be treated with injection atropine 0.6mg IV. Surgery will be allowed to start once sensory and motor blockade is achieved. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Any patient going for non-obstetric surgery under spinal anesthesia
2) American Society of Anesthesiologists (ASA) Grade I or II
3) BMI 18.5-24.9kg/m2 |
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Pregnant patients.
3. Any contraindication of spinal anesthesia.
4. Any spinal deformity.
5. Any patient with known hypersensitivity to ondansetron
6. Patients with comorbidities like diabetes, hypertension, asthma, tuberculosis.
7. Patients with conduction block.
8. Patient converted to general anesthesia |
|
|
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 |
| 1)To study the effect of ondansetron for prevention of spinal anesthesia induced hypotension. |
Till 60 mins post operatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To evaluate the beneficial effects of ondansetron.
2) To study the advantage of pre loading in patients going for surgery under spinal anesthesia.
3) To determine the adverse effects of ondansetron if any. |
Till 60 mins post operatively. |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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 4 |
|
Date of First Enrollment (India)
|
08/03/2024 |
| 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="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
|
The present study is a Prospective, Randomized Double Blind study done after approval of Institutional Ethics Committee satisfying all inclusion and exclusion criteria planned for any non-obstetric surgery under spinal anaesthesia.
Material used were Quincke type spinal needle of 25 gauge, Sterile 5 cc and 10 cc syringes. Bupivacaine 0.5% Heavy ampoule, Injection Ondansetron 8mg/4ml ampoule, Injection Atropine , Injection Mephenteramine, Emergency drugs, IV Fluids, Anaesthesia workstation, suction apparatus Laryngoscope and ET Tubes of various sizes.
After careful preoperative assessment of all patients’ standard monitors including NIBP, ECG, and pulse oximeter will be attached to the patient.
Anesthesiologist blinded to the prepared drug solution slowly administered 10 ml solution over 10 seconds. After 5 minutes, spinal anaesthesia will be performed in L3-L4 interspace with 25 G Quincke’s spinal needle using 3.0 ml of 0.5% heavy bupivacaine in sitting position. Patient will be immediately placed in supine position. SBP, DBP, MAP, HR and oxygen saturation will be recorded in individual proforma at the time of spinal anaesthesia and then at an interval of three minutes up to 15 minutes and then every 5minutes. Patients developing the primary endpoint of hypotension (systolic blood pressure 20% in baseline values) will be treated with injection mephentermine 6 mg IV, and those developing bradycardia (heart rate<50bpm) will be treated with injection atropine 0.6mg IV. Surgery will be allowed to start once sensory and motor blockade is achieved. |