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临床试验/CTRI/2025/10/096557
CTRI/2025/10/096557招募中不适用

Effect of preoperative anxiety and depression on intraoperative haemodynamics in spine surgery

未提供1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2026年1月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
90
试验地点
1
主要终点
To compare the correlation between anxiety/depression/stress and haemodynamic variation, in those with severe versus those with mild to moderate DASS 21 scores.

研究概览

简要总结

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.

  1. Patients coming for emergency / revision surgeries.

  2. Pregnancy.

  3. 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.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Adult patients aged between 18 and 65 years of either sex.
  • ASA I and ASA II undergoing general anaesthesia for elective spine surgeries.

排除标准

  • 未提供

结局指标

主要结局

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

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

次要结局

  • 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)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Madhava Pai

Kasturba Medical college and hospital, Manipal

研究点 (1)

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