FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/10/096557 [Registered on: 29/10/2025] Trial Registered Prospectively
Last Modified On: 12/10/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   To assess the relation between patients pre surgery stress/depression with parameters during surgery such as- blood pressure and pulse rate , in those undergoing spine surgery 
Scientific Title of Study   Effect of preoperative anxiety and depression on intraoperative haemodynamics in spine surgery 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
1  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Madhava Pai 
Designation  Associate professor  
Affiliation  Kasturba Medical college and hospital, Manipal 
Address  Department of Orthopaedics, Kasturba medical college and hospital, Manipal

Dakshina Kannada
KARNATAKA
576104
India 
Phone  9901729998  
Fax    
Email  madhava.pai@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Madhava Pai 
Designation  Associate professor  
Affiliation  Kasturba Medical college and hospital, Manipal 
Address  Department of Orthopaedics, Kasturba medical college and hospital, Manipal


KARNATAKA
576104
India 
Phone  9901729998  
Fax    
Email  madhava.pai@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Madhava Pai 
Designation  Associate professor  
Affiliation  Kasturba Medical college and hospital, Manipal 
Address  Department of Orthopaedics, Kasturba medical college and hospital, Manipal


KARNATAKA
576104
India 
Phone  9901729998  
Fax    
Email  madhava.pai@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical college and hospital, Manipal 
 
Primary Sponsor  
Name  None 
Address  nil 
Type of Sponsor  Other [] 
 
Details of Secondary Sponsor  
Name  Address 
None  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Madhava Pai  Kasturba medical hospital, manipal  Kasturba medical college and hospital , Manipal
Dakshina Kannada
KARNATAKA 		 9901729998

madhava.pai@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba medical college and kasturba hospital institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Adult patients aged between 18 and 65 years of either sex.
2. ASA I and ASA II undergoing general anaesthesia for elective spine surgeries.
 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the correlation between anxiety/depression/stress and haemodynamic variation, in those with severe versus those with mild to moderate DASS 21 scores.  To compare the correlation between anxiety/depression/stress and haemodynamic variation, in those with severe versus those with mild to moderate DASS 21 scores. 
 
Secondary Outcome  
Outcome  TimePoints 
Comparing difference in total opioids, vasopressors and anti-hypertensive agents used in group with severe versus those with mild-moderate DASS 21 scores. Satisfaction scores at discharge between the two groups.   Intraoperatively, post operatively till discharge 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   01/01/2026 
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)  Open to Recruitment 
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  

Aims & objectives (hypotheses if applicable):

To assess the prevalence of preoperative anxiety and depression in patients scheduled to undergo spine surgery and assess their intraoperative haemodynamics.

Hypotheses- Patients with higher anxiety or depression scores have more haemodynamic variation intraoperatively.

Justification for study (whether of national significance with rationale):

Spine surgery is considered to be one of the most painful surgeries, due to its complexity and extent of surgery. Various studies have demonstrated the association between preoperative anxiety and depression and postoperative outcomes in spine surgery.But there is very limited literature on the effects of preoperative anxiety and depression on intraoperative haemodynamics, especially in the Indian population. By analysing association between the two factors, we aim to emphasise the value of treating preoperative anxiety and depression to improve intraoperative management and ultimately improve patient satisfaction. 

 INCLUSION CRITERIA:

1. Adult patients aged between 18 and 65 years of either sex.

2. ASA I and ASA II undergoing general anaesthesia for elective spine surgeries.

EXCLUSION CRITERIA:

1. Patient refusal.

2. Body mass index more than 35 

3. Patients with severe psychiatric or neurological disease / taking psychiatric medication / those who require reference to psychiatrist.

4. Chronic alcoholic patients

5.Patients with severe cardiac, coronary, renal, hepatic, cerebral diseases and peripheral vascular diseases.

6. Patients coming for emergency / revision surgeries.

7. Pregnancy.

8. Neuromuscular disorder.

 Statistical methods:

Data will be analysed using IBM SPSS ver. 21.0 (IBM Corp., Armonk, NY, USA). The data will be tested for normality using histogram and Shapiro–Wilk normality test (p-value more than 0.05 will be taken as normally distributed). Normally distributed and continuous data will be analysed using student t-test and non-normally distributed data will be analysed using Mann Whitney U test. The comparisons of categorical variable will be analysed using Pearson chi-square test. Data will be presented as mean plus or minus SD for normally distributed, median ± IQR for non-normally distributed and categorical data will be presented as numbers and frequencies (percentages). P-value less than 0.05 will be considered as statistically significant.

 Detailed description of procedure / processes:

Following institutional ethics committee clearance, this prospective cross-sectional study will be conducted after obtaining CTRI number, over the course of 1 year.

After obtaining a written informed consent, all patients will be preoperatively evaluated for depression/anxiety/ stress using the DASS12 Scale. The data will be collected through interviews using a structured questionnaire during preoperative assessment and on arrival to the operation room.

Hemodynamic status -mean arterial blood pressure(MAP), Systolic blood pressure (SBP), Diastolic Blood pressure (DBP), Heart rate(HR) and Oxygen saturation (SpO2)-will be measured and documented during anaesthesia preoperative assessment, on arrival to the operation room, before induction of anaesthesia, after induction of anaesthesia, intraoperatively at 5th, 10th, 30th, 50th, 70th, 90th minute by an anaesthesiologist  who will not know the DASS12 scores measured preoperatively.

For this study, the following definitions will be used:

Hypertension: increments of arterial blood pressure by 20% from the baseline.

Hypotension-20% decrease in arterial blood pressures from baseline.

Tachycardia: increment in heart rate above 100 beat per minutes.

Bradycardia: decrement in heart rate below 60 beat per minutes.

The total intraoperative opioids, vasopressors and anti-hypertensive agent use will also be noted.

Post surgery, Time to recovery after switching off all anaesthetic agents, duration of postoperative anaesthesia care unit (PACU) Stay and Satisfaction score will be recorded.

 

  Outcome measures:

Primary outcomes to be measured:

To compare the correlation between anxiety/depression/stress and haemodynamic variation, in those with severe versus those with mild to moderate DASS 21 scores.

Secondary outcomes measured:

Comparing difference in total opioids, vasopressors and anti-hypertensive agents used in group with severe versus those with mild-moderate DASS 21 scores. Satisfaction scores at discharge between the two groups. 

 

 

 

 


 
Close