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Clinical Trials/NCT04432558
NCT04432558CompletedNot Applicable

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

Baskent University1 site in 1 country42 target enrollmentStarted: April 12, 2017Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
42
Locations
1
Primary Endpoint
Does Preoperative anxiety level effect postoperative pain?

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Female patients aged between 18-65 years old
  • 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

Arms & Interventions

Preoperative anxiety level

Intervention: Spielberger's State-Trait Anxiety Inventory (Diagnostic Test)

Postoperative pain and analgesic consumption

Intervention: Visual analog scale, Ramsay's sedation scale (Other)

Postoperative pain and analgesic consumption

Intervention: Tramadol, paracetamol, diclofenac sodium (Drug)

Outcomes

Primary Outcomes

Does Preoperative anxiety level effect postoperative pain?

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yonca Özvardar Pekcan

Medical doctor. Anaesthesia and reanimation specialist

Baskent University

Study Sites (1)

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