Skip to main content
OpenTrials
Completed

NCT Number: NCT04432558

Postoperative Effects of Preoperative Anxiety

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Baskent University Zubeyde Hanim Practice and Research Center

Izmir, Karşıyaka, 35540, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spielberger's State-Trait Anxiety Inventory

Diagnostic Test

Patients will be wanted to fill the Spielberger's State-Trait Anxiety Inventory the night before the surgery.

Visual analog scale, Ramsay's sedation scale

Other

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.

Tramadol, paracetamol, diclofenac sodium

Drug

The analgesic consumption of the patients will be recorded

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Baskent University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Jun 16, 2020
Registry last updated
Jul 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.