Postoperative Effects of Preoperative Anxiety

Study Overview
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Brief Summary
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INTRODUCTION Patients who will have obesity surgery have about %48 psychiatric illnesses like anxiety disorder. Studies which analyze the relationship between preoperative anxiety level and postoperative pain had reported conflicting results. The aim of this study is to search the relationship between preoperative anxiety level and postoperative pain and analgesic consumption in patients who had laparoscopic sleeve gastrectomy surgery. MATERIAL AND METHODS Our prospective double-blind study is planned to require 86 female patients aged between 18-65 years old, American Society of Anesthesiologists (ASA) I-II and Body mass index (BMI) ≥40 kg/m^2. Patients having a psychiatric or neurologic disease, brain damage, using psychiatric medications (antidepressants, anxiolytics) and chronic alcohol, known allergy to medications used in the study protocol, inability to provide informed consent will be excluded. Patients will be wanted to fill the Spielberger's State-Trait Anxiety Inventory the night before the surgery. The analgesic consumption of the patients will be recorded by evaluating the pain with Visual analog scale (VAS) and sedation status with Ramsay's sedation scale in the 1st, 4th, 12th and 24th hour of postoperative period. EXPECTATIONS AND SCIENTIFIC CONTRIBUTIONS More satisfying postoperative analgesia may be provided in this group of patients by determining correlation between preoperative anxiety level and postoperative pain and analgesic consumption in patients who had laparoscopic sleeve gastrectomy. Morbidity rate related with pain may be decreased and patient satisfaction may be increased.

Official Title
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The Effect of Preoperative Anxiety Level to Postoperative Pain and Analgesic Consumption in Patients Who Had Laparoscopic Sleeve Gastrectomy

Conditions
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Anxiety, Pain, Postoperative

Intervention / Treatment
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* Diagnostic Test: Spielberger's State-Trait Anxiety Inventory
* Other: Visual analog scale, Ramsay's sedation scale
* Drug: Tramadol, paracetamol, diclofenac sodium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients aged between 18-65 years old ASA I-II BMI ≥35 kg/m^2 Exclusion Criteria: Having a psychiatric or neurologic disease Brain damage Using psychiatric medications (antidepressants, anxiolytics) and chronic alcohol Known allergy to medications used in the study protocol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Preoperative anxiety level<br> | Diagnostic Test: Spielberger's State-Trait Anxiety Inventory<br>* Patients will be wanted to fill the Spielberger's State-Trait Anxiety Inventory the night before the surgery.<br>|
| Postoperative pain and analgesic consumption<br> | Other: Visual analog scale, Ramsay's sedation scale<br>* The analgesic consumption of the patients will be recorded by evaluating the pain with VAS (Visual analog scale) and sedation status with Ramsay's sedation scale in the 1st, 4th, 12th and 24th hour of postoperative period.<br>Drug: Tramadol, paracetamol, diclofenac sodium<br>* The analgesic consumption of the patients will be recorded<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Does Preoperative anxiety level effect postoperative pain? | More satisfying postoperative analgesia may be provided in this group of patients by determining correlation between preoperative anxiety level and postoperative pain and analgesic consumption in patients who had laparoscopic sleeve gastrectomy.Patients will be wanted to fill the Spielberger's State-Trait Anxiety Inventory the night before the surgery. The analgesic consumption of the patients will be recorded by evaluating the pain with Visual analog scale (VAS) and sedation status with Ramsay's sedation scale in the 1st, 4th, 12th and 24th hour of postoperative period. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preoperative anxiety level, Postoperative pain, Laparoscopic sleeve gastrectomy