| CTRI Number |
CTRI/2022/08/044629 [Registered on: 04/08/2022] Trial Registered Prospectively |
| Last Modified On: |
03/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
TO ASSESS THE EFFECTIVENESS OF KETAMINE AS PREMEDICANT FOR PREVENTING FALL IN BLOOD PRESSURE AFTER SPINAL ANAESTHESIA IN PARTURIENTS POSTED FOR ELECTIVE CAESAREAN SECTION- A PROSPECTIVE RANDOMIZED DOUBLE BLIND CONTROLLED STUDY |
|
Scientific Title of Study
|
EFFICACY OF INTRAVENOUS KETAMINE AS PREMEDICANT FOR PREVENTION OF INTRA- OPERATIVE HYPOTENSION AFTER SPINAL ANAESTHESIA IN PARTURIENTS POSTED FOR ELECTIVE CAESAREAN SECTION- A PROSPECTIVE RANDOMIZED DOUBLE BLIND CONTROLLED STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SAMBREKAR SUDEEPTA MADAN |
| Designation |
Post graduate |
| Affiliation |
JSS MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, JSS MEDICAL COLLEGE AND HOSPITAL, RAMACHANDRA, AGRAHARA, MYSURU
Mysore KARNATAKA 570004 India |
| Phone |
8762559174 |
| Fax |
|
| Email |
sudeeptams2426@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
PROF Dr MANJULA B P |
| Designation |
PROFESSOR |
| Affiliation |
JSS MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, JSS MEDICAL COLLEGE AND HOSPITAL, RAMACHANDRA, AGRAHARA, MYSURU
Mysore KARNATAKA 570004 India |
| Phone |
9845501226 |
| Fax |
|
| Email |
bpmanjula5@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
PROF Dr MANJULA B P |
| Designation |
PROFESSOR |
| Affiliation |
JSS MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, JSS MEDICAL COLLEGE AND HOSPITAL, RAMACHANDRA, AGRAHARA, MYSURU
Mysore KARNATAKA 570004 India |
| Phone |
9845501226 |
| Fax |
|
| Email |
bpmanjula5@gmail.com |
|
|
Source of Monetary or Material Support
|
| JSS MEDICAL COLLEGE AND HOSPITAL |
|
|
Primary Sponsor
|
| Name |
JSS MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, JSS MEDICAL COLLEGE AND HOSPITAL, RAMACHANDRA, AGRAHARA, MYSURU 570004 |
| Type of Sponsor |
Private 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 |
| SAMBREKAR SUDEEPTA MADAN |
JSS MEDICAL COLLEGE AND HOSPITAL |
OT COMPLEX, DEPARTMENT OF ANAESTHESIOLOGY Mysore KARNATAKA |
8762559174
sudeeptams2426@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 1||Obstetrics, (2) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
KETAMINE |
15 MG OF KETAMINE BOLUS DOSE WILL BE GIVEN INTRAVENOUSLY TO ONE GROUP JUST BEFORE INJECTING SPINAL DRUG. |
| Comparator Agent |
NORMAL SALINE |
15 ML OF NORMAL SALINE WILL BE GIVEN INTRAVENOUSLY TO OTHER GROUP JUST BEFORE INJECTING SPINAL DRUG. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
PARTURIENTS OF ASA PHYSICAL CLASS II UNDERGOING ELECTIVE LOWER SEGMENT CAESAREAN SECTION UNDER SPINAL ANAESTHESIA. |
|
| ExclusionCriteria |
| Details |
1. CONTRAINDICATIONS TO REGIONAL ANAESTHESIA
2. PARTURIENTS WITH PLACENTA PREVIA, PREECLAMPSIA, CARDIOVASCULAR OR CEREBROVASCULAR DISEASE, GESTATIONAL DIABETES.
3. GESTATIONAL AGE <36 WEEKS OR > 41 WEEKS.
4. PRE- EXISTING ABNORMAL NEUROLOGICAL OR PSYCHIATRIC DISEASES.
5. HISTORY OF ALLERGY TO KETAMINE.
6. BMI >30 KG/M2.
7. PARTURIENT HEIGHT <150 CM OR > 170 CM. |
|
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Method of Generating Random Sequence
|
Other |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO STUDY THE INCIDENCE OF HYPOTENSION AFTER SPINAL ANAESTHESIA IN CAESAREAN SECTION. |
THE FIRST 60 MINUTES FOLLOWING SPINAL ANAESTHESIA WILL BE CONSIDERED FOR ANAESTHESIA INDUCED HYPOTENSION. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO STUDY THE POSTOPERATIVE ANALGESIC AND SEDATIVE EFFECT OF KETAMINE, TO STUDY THE FETAL OUTCOME BY ASSESSING THE APGAR SCORE |
5 MINUTES UPTILL 24 HOURS |
|
|
Target Sample Size
|
Total Sample Size="98" Sample Size from India="98"
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)
|
04/08/2022 |
| 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="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Informed and written consent will be taken from 98 parturients of American Society of Anaesthesiologists Physical status (ASA) class II undergoing elective lower segment caesarean section under spinal anaesthesia. Randomization of parturients will be done by shuffled sealed opaque envelope technique. A thorough pre- anaesthetic evaluation will be done 24 hours prior to the procedure. Standard monitoring with electrocardiography (ECG), automated non-invasive blood pressure (NIBP) and pulse oximetry (saturation- SpO2) will be done for baseline values and intraoperative monitoring using a multipara meter Philips IntelliVue MP20/MP30 monitor. Parturients will be divided into two groups:- GROUP K:- Those who will receive 15 mg of intravenous Ketamine in 3 ml of normal saline. GROUP C:- Those who will receive 3 ml of normal saline. This will be a double-blind study. The study drugs will be prepared by the same anaesthesiologist who does the randomization and administered by the observer. Hence, the observer and parturient will be blinded to the study drugs. The baseline hemodynamic values will be recorded in the supine position (with wedge under the right buttock to prevent aortocaval obstruction). Intravenous (IV) access will be established in the upper limb. Each parturient will be started on IV infusion of Ringer lactate at 5- 7 ml/kg prior to the subarachnoid block (SAB) in the operating room. The baseline values of SBP (systolic blood pressure), DBP (diastolic blood pressure), MAP (mean arterial pressure), HR (heart rate), ECG and saturation will be recorded. The parturients will then be turned to lateral position. The study drugs will be administered by the observer immediately before the injection of the spinal agent. Spinal anaesthesia will be performed using Quincke’s 25 gauge spinal needle in lateral position with 10 mg of injection bupivacaine 0.5% (hyperbaric) at the L3–L4 interspace with midline approach. The parturient will return to the supine position immediately with a wedge under the right buttock to prevent aortocaval obstruction. Oxygen will be supplemented through face mask at 4L/min. Ringer lactate will be administered at a rate of 100 ml/10 min. The onset and level of sensory block will be checked 5 minutes after the spinal injection and the surgery will be allowed to start after the confirmation of sensory block to T6 level. Maximum level of sensory and motor blockade will be recoded. If a T6 sensory block level is not achieved, these parturients will be excluded from the study and managed according to the institutional protocol. NIBP, HR, respiratory rate (RR) and SpO2 will be recorded at 2 minutes intervals after the SAB up to 20 minutes and then at 5 minutes intervals till the end of surgery. Hypotension defined as a decrease in SBP <20% of baseline or <90mmHg will be recorded and treated with IV bolus of 6mg injection ephedrine. The number of incidences of hypotension, total amount of ephedrine required and number of doses of ephedrine required will be recorded. The first 60 minutes following spinal anaesthesia will be considered for anaesthesia-induced hypotension. Following extraction of the baby, APGAR score will be recorded at 1 and 5 minutes. Injection oxytocin 10 units will be given as uterotonic following baby extraction intramuscularly. Parturients requiring any additional oxytocin and/or additional surgical interventions will be excluded from the study. Postoperative monitoring of SBP, DBP, MAP, HR, ECG and SPO2 will be done every hourly for first 6 hours. Post-operative pain will be assessed using the visual analogue scale (VAS). VAS consists of a 10 cm line with 0 equaling “no pain at all†and 10 being the “worst possible pain†11. The pain will be monitored every 2 hours for first 6 hours and then every 6th hourly for next 18 hours or until first complaint of pain called the “time to first breakthrough pain†which will be considered as the pain requiring treatment (VAS>/= 4 ). Rescue analgesic injection diclofenac 75mg will be given intramuscularly. The number of doses given will be recorded. Ramsay sedation scale will be used to evaluate the sedative effect at baseline, then at 5, 10, 15, 30, 45 minutes after intrathecal injection and then at the end of the operation 1. Ramsay score | Level of sedation | 1 | Anxious, agitated, restless | 2 | Oriented, tranquil | 3 | Responds to commands | 4 | Brisk response to light glabellar tap | 5 | Sluggish response to light glabellar tap | 6(deep sedation) | No response | The incidence of other adverse events such as nausea, vomiting and mood changes if observed any will be recorded. |