Postoperative Effects of Preoperative Anxiety

Completed

• Conditions: Anxiety; Pain, Postoperative
• Interventions: Other: Visual analog scale, Ramsay's sedation scale; Diagnostic Test: Spielberger's State-Trait Anxiety Inventory; Drug: Tramadol, paracetamol, diclofenac sodium

• Registration Number: NCT04432558
• Lead Sponsor: Baskent University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-12
• Study First Submitted: 2020-06-05
• Study First Submitted QC: 2020-06-12
• Study First Posted: 2020-06-16
• Primary Completion: 2020-12-31
• Study Completion: 2021-01-30
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-20
• Last Update Posted: 2021-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 42

Inclusion Criteria

• Female patients aged between 18-65 years old
• ASA I-II
• BMI ≥35 kg/m^2

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Postoperative pain and analgesic consumption	Visual analog scale, Ramsay's sedation scale	-
Postoperative pain and analgesic consumption	Tramadol, paracetamol, diclofenac sodium	-
Preoperative anxiety level	Spielberger's State-Trait Anxiety Inventory	-

Primary Outcome Measures

Name	Time	Method
Does Preoperative anxiety level effect postoperative pain?	5 years	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.

Trial Locations

Locations (1)

Baskent University Zubeyde Hanim Practice and Research Center; 🇹🇷 İzmir, Karşıyaka, Turkey