Postoperative Effects of Preoperative Anxiety

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04432558
• Other study ID #: K17/24
• Status: Completed
• Start date: April 12, 2017
• Est. completion date: January 30, 2021

Study information

• Verified date: July 2021
• Source: Baskent University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: January 30, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Pain, Postoperative

Intervention

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

Locations

Country	Name	City	State
Turkey	Baskent University Zubeyde Hanim Practice and Research Center	Izmir	Karsiyaka

Sponsors (1)

Lead Sponsor	Collaborator
Baskent University

Country where clinical trial is conducted

Turkey, 

References & Publications (28)

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Does Preoperative anxiety level effect postoperative pain?	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.	5 years