| CTRI Number |
CTRI/2019/05/019071 [Registered on: 13/05/2019] Trial Registered Prospectively |
| Last Modified On: |
12/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
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Type of Study
|
Prospective , longitudinal |
| Study Design |
Other |
|
Public Title of Study
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To study the relation between anxiety and lowering of blood pressure in the patients after receiving injection in back for undergoing caesarean section. |
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Scientific Title of Study
|
Correlation of preoperative anxiety and post spinal hypotension in patients undergoing caesarean section |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr PRACHI MORE |
| Designation |
MD ANAESTHESIA JUNIOR RESIDENT |
| Affiliation |
LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND GENERAL HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND GENERAL HOSPITAL, SION, MUMBAI-22
Mumbai MAHARASHTRA 400022 India |
| Phone |
9820938785 |
| Fax |
|
| Email |
prachimore1388@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr DEEPTI KOTWANI |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND GENERAL HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND GENERAL HOSPITAL, SION, MUMBAI-22
Mumbai MAHARASHTRA 400022 India |
| Phone |
9870135926 |
| Fax |
|
| Email |
drdeeptiagrawal@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr DEEPTI KOTWANI |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND GENERAL HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND GENERAL HOSPITAL, SION, MUMBAI-22
Mumbai MAHARASHTRA 400022 India |
| Phone |
9870135926 |
| Fax |
|
| Email |
drdeeptiagrawal@gmail.com |
|
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Source of Monetary or Material Support
|
| LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND GENERAL HOSPITAL |
|
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Primary Sponsor
|
| Name |
LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND GENERAL HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND GENERAL HOSPITAL, SION, MUMBAI-22 |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr PRACHI MORE |
LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND GENERAL HOSPITAL, SION |
WARD 12,LABOUR WARD AND OBSTETRICS THEATRE Mumbai MAHARASHTRA |
9820938785
prachimore1388@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND GENERAL HOSPITAL |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O746||Other complications of spinal andepidural anesthesia during labor and delivery, |
|
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Intervention / Comparator Agent
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
All consenting pregnant patients above age of 18 years, posted for elective and emergency Caeserean section receiving spinal anaesthesia will be included for the study |
|
| ExclusionCriteria |
| Details |
1) Patients with complicated pregnancy (abruptio placenta/ placenta praevia)
2) Patients having Preeclampsia
3) Patients with preexisting / gestational hypertension
4) Patients with anaemia (Hb<9)
5) Patients with heart, pulmonary, renal or liver disease
6) Patients with psychiatric disorders
7) Inadequate time for anxiety assessment
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| To study the correlation between preoperative anxiety and hypotension in patients undergoing Caesarean section under spinal anaesthesia. |
Patients will be assessed at the following time intervals:
1) Baseline assessment
2) Before spinal anaesthesia
3) After spinal anaesthesia( 2mins, 4mins, 6mins, 8mins, 10mins, 15mins, 20mins, 25mins, 30mins) |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1. To determine the difference in the need of vasopressors between the different anxiety groups.
2. To determine difference in the level of preoperative anxiety in the patients presenting for elective and emergency Caesarean section
|
Patients will be assessed at the following time intervals:
1) Baseline assessment
2) Before spinal anaesthesia
3) After spinal anaesthesia( 2mins, 4mins, 6mins, 8mins, 10mins, 15mins, 20mins, 25mins, 30mins) |
|
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Target Sample Size
|
Total Sample Size="150" Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/05/2019 |
| 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="10" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
Not yet |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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This observational prospective longitudinal study will be performed after approval from the institutional ethics committee. All the parturients satisfying the inclusion criteria will be included in our study. Written informed consent will be taken from the patients. Their preoperative anxiety scores will be assessed in the preoperative ward using two standard and validated Scales which measure anxiety: 1.Verbal Analogue Scale (VAS) anxiety – Parturients will be asked to rank subjective anxiety on a VAS scale of 0 to 10; where 0 is no anxiety at all and 10 the worst anxiety imaginable. The VAS score obtained will be converted to ordinal data as under: â€VAS of0 to 3 à Low Anxiety â€VAS of 4 to 6 à Moderate Anxiety â€VAS of 7 to 10 à High Anxiety
2. The Amsterdam Preoperative Anxiety and Information Scale (APAIS Scale) | APAIS question | Not at all |
| | | Extremely | | 1. I am worried about the anaesthetic. | 1 | 2 | 3 | 4 | 5 | | 2. The anaesthetic is on my mind continually. | | | | | | | 3. I would like to know as much as possible about the anaesthetic. | | | | | | | 4. I am worried about the procedure. | | | | | | | 5. The procedure is on my mind continually. | | | | | | | 6. I would like to know as much as possible about the procedure | | | | | |
The questionnaire consists of two sub scales, both the Anxiety subscale and the Information Need scale. The instrument has 6 questions rated by the patient on a 5-point scale. The Anxiety Subset score (sum C = sum A + sum S) is calculated as the sum of anaesthesia anxiety (sum A =1+2 questions), sum of surgical anxiety (sum S = 4 + 5 questions) and the need for information score is the sum of items 3 and 6. Each statement in APAIS is rated on 5 point scale; 1 not at all; 2 somewhat; 3 moderately so; 4 very much so; 5 extremely. APAIS anxietyscores (sum C) = 4-9 à Low anxiety, 10-14 à Moderate anxiety 15-20 à high anxiety. Base Line Haemodynamic parameters (Heart rate, systolic and diastolic blood pressure) will be noted following this anxiety score assessment. As our institutional practice, following explanation of procedure and written informed valid consent,standard anaesthesia practice is giving spinal anaesthesia in the sitting position using hyperbaric Bupivacaine. On achieving sensory level of T6, surgery is started. Patients with partial or inadequate sensory blockade or achieving sensory levels above T5 will be excluded from the study. In case of any Intraoperative Obstetric complications (like excessive Blood loss, postpartum haemorrhage etc.) the patient will be excluded from the study and the conduct of anaesthesia will follow the standard protocol. However, occurrence of such complications will be noted. Heart rate, Non invasive arterial blood pressure (NIBP) will be measured and recorded at baseline, before administrating spinal anaesthesia and every 2 minute after spinal anaesthesia for first 10 minutes followed by every 5 minutes for next 30 minutes. Time of baby delivery will be noted. Fall in Systolic blood pressure (SBP) by >20 % below baseline will be considered as hypotension and will be treated as per discretion of the involved anaesthesiologist. Requirement of vasopressors and intravenous fluid boluses needed, will be noted. Parameters noted will be – 1.Demographic Data (Age, Height, Weight, Educational Status,Parity) 2.Previous exposure to surgery & anaesthesia 3.Pre-operative Anxiety Score (VAS & APAIs) (Appendix B) 4.Level of Spinal Block (Sensory) 5.Haemodynamic Parameters: Heart Rate, Systolic and Diastolic Blood Pressure, in the supine position at the following events ·On preoperative assessment (Baseline) ·In the operating room - on Table ·Following spinal anaesthesia after patient is made supine ·Every 2 minutes after spinal anaesthesia for first 10 minutes followed by every 5 minutes for next 30 minutes 6. Vasoressors requirement |