CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 42 enrolled
Drug / intervention
Tramadol, paracetamol, diclofenac sodium +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04432558
NCT04432558N/ACompleted

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

Baskent University·observational·Posted Jun 16, 2020·Updated Jul 21, 2021

In Brief

An observational study evaluating Spielberger's State-Trait Anxiety Inventory, Visual analog scale, Ramsay's sedation scale, and 1 other intervention for Anxiety and Pain, Postoperative. Completed, enrolled 42 participants across 1 site.

Detailed 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 Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesTurkey (Türkiye)
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJun 16, 2020
Enrollment StartApr 12, 2017
Primary CompletionDec 31, 2020
Study CompletionJan 30, 2021
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 6.0 years ago

Interventions

Spielberger's State-Trait Anxiety Inventoryother

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

Visual analog scale, Ramsay's sedation scaleother

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 sodiumdrug

The analgesic consumption of the patients will be recorded