NCT04432558

Postoperative Effects of Preoperative Anxiety

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 42 (actual)
• Sponsor: Baskent University · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Anxiety
• Pain, Postoperative

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Spielberger's State-Trait Anxiety Inventory	Patients will be wanted to fill the Spielberger's State-Trait Anxiety Inventory the night before the surgery.
OTHER	Visual analog scale, Ramsay's sedation scale	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.
DRUG	Tramadol, paracetamol, diclofenac sodium	The analgesic consumption of the patients will be recorded

Timeline

• Start date: 2017-04-12
• Primary completion: 2020-12-31
• Completion: 2021-01-30
• First posted: 2020-06-16
• Last updated: 2021-07-21

Locations

1 site across 1 country: Turkey (Türkiye)

Regulatory

• FDA-regulated drug study