Ankara Atatürk Sanatorium Training and Research Hospital
Ankara, Keçiören, 06290, Turkey (Türkiye)
NCT Number: NCT06310850
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 3
Ankara, Keçiören, 06290, Turkey (Türkiye)
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; ID:238), 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 (n=30) receiving an intravenous placebo and Group K (n=30) receiving intravenous (IV) 0.15 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 0.15 mg/kg IV ketamine or placebo will take place 3 minutes before TEC placement.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will be administered 0.15 mg kg-1 intravenous ketamine (The sample provided contains equal proportions of two enantiomers, S and R ketamine hydrochloride.) 3 minutes before thoracic epidural catheter placement.
Intravenous saline will be administered to patients 3 minutes before the thoracic epidural catheter is placed.
Time frame: 1 day (5 times)
For anxiety, on a 100 mm scale, 0 mm was defined as no anxiety, whereas 100 mm was as unbearable anxiety (VAS-A). A similar scoring method was used to assess pain intensity. 0 mm was defined as no pain and 100 mm as unbearable pain (VAS-P).
Ankara Ataturk Sanatorium Training and Research Hospital
Other Gov
The Effect of Preprocedural Subanesthetic Ketamine for Pain and Anxiety in Patients During Thoracic Epidural Catheterization: A Randomized Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07056166
Epidural Catheterization
Padua, Italy
View Trial DetailsNCT07632625
Anxiety Disorders, Mental Disorders
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT06994637
Anxiety Disorders, Anxiety and Fear
Hakkari, Turkey (Türkiye)
View Trial DetailsNCT07312084
Anxiety, Anxiety Disorders
View Trial Details