Clinical trial NCT04432558: Postoperative Effects of Preoperative Anxiety
Official title: The Effect of Preoperative Anxiety Level to Postoperative Pain and Analgesic Consumption in Patients Who Had Laparoscopic Sleeve Gastrectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety
Pain, Postoperative
Keywords: Preoperative anxiety level
Postoperative pain
Laparoscopic sleeve gastrectomy
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female patients aged between 18-65 years old, ASA I-II, which BMI ≥35 kg/m\^2 and have bariatric surgical indications because of morbid (type III) obesity

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.


Eligibility criteria: 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

Primary outcomes:
measure: Does Preoperative anxiety level effect postoperative pain?
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Baskent University Zubeyde Hanim Practice and Research Center
state: Karşıyaka
Study officials:
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