Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06310850
Status:
COMPLETED
Last Update Posted:
2024-03-15
First Post:
2024-03-05
Brief Title:
The Effect of Preprocedural Subanesthetic Ketamine on Pain and Anxiety
Sponsor:
Ankara Ataturk Sanatorium Training and Research Hospital
Organization:
Ankara Ataturk Sanatorium Training and Research Hospital
Study Overview
Official Title:
The Effect of Preprocedural Subanesthetic Ketamine for Pain and Anxiety in Patients During Thoracic Epidural Catheterization A Randomized Trial
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The thoracic epidural catheterization TEC can be both uncomfortable and fearful for patients when done awake with the thought that the procedure may be painful The aim of this study was to assess the effect of subanesthetic intravenous ketamine administration on pain and anxiety during the TEC procedure
Detailed Description:
The study aimed to assess the impact of subanesthetic intravenous ketamine administration on pain and anxiety during Thoracic Epidural Catheterisation TEC procedure which can be uncomfortable and frightening for patients when performed awake due to the possibility of pain
After receiving approval from the clinical research ethics committee of Keçiören Education and Research Hospital KEAH ID238 this prospective and randomized study will include 60 adult patients with ASA physical status I-III who are scheduled for elective thoracic surgery via thoracotomy The study will randomly assign patients into two groups Group P n30 receiving an intravenous placebo and Group K n30 receiving intravenous IV 015 mg kg-1 ketamine Randomisation will be performed using a computerised table of random numbers
Patients with chronic pain bleeding disorders drug use liver disease severe metabolic and endocrine problems a history of ketamine or local anaesthetic allergy infection at the site of intervention or refusal of TEC will be excluded Patients who report acute pain during preoperative evaluation have a TEC time of more than five minutes from needle insertion to catheter insertion and require more than two Tuohy needle attempts will be excluded Vital parameters and anxiety levels of each patient will be recorded before premedication Anxiety VAS-A and pain VAS-P scores will be measured using the visual analogue scale Patients will be transported to the operating theatre 20 minutes after premedication Intravenous administration of 015 mgkg IV ketamine or placebo will take place 3 minutes before TEC placement
After receiving approval from the clinical research ethics committee of Keçiören Education and Research Hospital KEAH ID238 this prospective and randomized study will include 60 adult patients with ASA physical status I-III who are scheduled for elective thoracic surgery via thoracotomy The study will randomly assign patients into two groups Group P n30 receiving an intravenous placebo and Group K n30 receiving intravenous IV 015 mg kg-1 ketamine Randomisation will be performed using a computerised table of random numbers
Patients with chronic pain bleeding disorders drug use liver disease severe metabolic and endocrine problems a history of ketamine or local anaesthetic allergy infection at the site of intervention or refusal of TEC will be excluded Patients who report acute pain during preoperative evaluation have a TEC time of more than five minutes from needle insertion to catheter insertion and require more than two Tuohy needle attempts will be excluded Vital parameters and anxiety levels of each patient will be recorded before premedication Anxiety VAS-A and pain VAS-P scores will be measured using the visual analogue scale Patients will be transported to the operating theatre 20 minutes after premedication Intravenous administration of 015 mgkg IV ketamine or placebo will take place 3 minutes before TEC placement
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None