The Effect of Premedication on Postoperative Pain and Anxiety in Breast Cancer Surgery

The Effect of Premedication Methods to be Applied to Prevent Preoperative Anxiety in Patients Who Will be Operated for Breast Cancer, on Postoperative Anxiety and Pain

In this study, it was investigated whether the premedication drug administered before the surgery had an effect on postoperative pain and anxiety scores in female patients under the age of 65 who will undergo breast cancer surgery.

Study Overview

• Status: Recruiting
• Conditions: Female Patients Under the Age of 65 Who Will Undergo Breast Cancer Surgery
• Intervention / Treatment: Drug: Precedex and dormicum

Detailed Description

In this study, it was investigated whether the premedication drug administered before the surgery had an effect on postoperative pain and anxiety scores in female patients under the age of 65 who will undergo breast cancer surgery. The STAI-1(State Trait Anxiety İnventory ) form and APAIS (Amsterdam Preoperative Anxiety and İnformation Scale) scale were filled in for all preoperative patients. Afterwards, the patients were treated with either midazolam or dexmedetothymidine, depending on the anesthesiologist's preference. After administration, he was taken to surgery. As intraoperative analgesics, 2 mg/kg tramadol and 15 mg/kg paracetamol were administered to all patients. postoperative recovery time (aldrete 10), 1., 2.,6.,12.,24. VAS score, postoperative nausea-vomiting scale, STAI-1(State Trait Anxiety İnventory ) form, first need time if postoperative analgesic was needed, and 24-hour total analgesic consumption were recorded. It was aimed to examine the effects of different premedications on postoperative pain and anxiety

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Seyda ARİ; Phone Number: +905382598442; Email: seyda93.ari@yandex.com
• Study Contact Backup: Name: Guldeniz ARGUN; Phone Number: +905336230405; Email: guldargun@yahoo.com

Study Locations

• Turkey
  • Ankara, Turkey
    • Recruiting
    • AbdurrahmanYAOTRH
    • Contact: Abdurrahman Yurtaslan Onkoloji Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

ASA 1-2-3, female patients aged 18-65 who will undergo breast cancer surgery

Description

Inclusion Criteria:

• ASA 1-2-3
• 18-65 aged
• Female patients

Exclusion Criteria:

• Under 18 years old and over 65 years old
• Having a history of cerebrovascular disease illiteracy
• Have visual and auditory problems İnability to cooperate with cognitive function test
• Having emergency surgery
• Those who are unable to read, understand and sign the consent form
• Patients deemed unsuitable by the investigator

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
low dose midazolam; 0,025 mg/kg Midazolam	Drug: Precedex and dormicum; Premedication
high dose midazolam; 0,05 mg/kg Midazolam	Drug: Precedex and dormicum; Premedication
low dose dexmedetothymidine; 0.5 mg/kg dexmedetothymidine 10 minute infusion	Drug: Precedex and dormicum; Premedication
high dose dexmedetothymidine; 1mg/kg dexmedetothymidine 10 minute infusion	Drug: Precedex and dormicum; Premedication

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
effect of premedication on postoperative pain and anxiety scores	November 2022-December 2022

Collaborators and Investigators

• Sponsor: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2022
• Primary Completion (Actual): November 28, 2022
• Study Completion (Anticipated): January 30, 2023

Study Registration Dates

• First Submitted: December 3, 2022
• First Submitted That Met QC Criteria: December 3, 2022
• First Posted (Estimate): December 12, 2022

Study Record Updates

• Last Update Posted (Estimate): December 12, 2022
• Last Update Submitted That Met QC Criteria: December 3, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam; Dexmedetomidine
• Other Study ID Numbers: 2022-09/2057

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No