Anxiety Clinical Trial - Preoperative Anxiety Level, Premedications &

Status Completed

Clinical Trial Summary

Although it seems obvious that the high level of preoperative anxiety may affect intraoperative anaesthetic requirements and recovery adversely, there are several contradictory studies about this subject. Furthermore, the effects of anxiolytic premedication are actually disputed: sedative premedication is widely administered but little clinical evidence supports its use.

We want to evaluate the effects of pre-procedure anxiety for propofol needs in patients receiving general anaesthetic procedure. We also want to know if premedication is useful according to the preoperative anxiety level, in order to determine if a sub-group of patients benefit from it.

Clinical Trial Description

This study will be carried out in solely at the institute of CHU de Reims, France (Reims Teaching Hospital) from March 2017 to May 2017. Selected patients will be over the age of 18, among those receiving general anaesthesia for surgery. Demographic data and medical history will be collected after written consent. Before the anaesthetic procedure, an APAIS questionnaire (Anxiety evaluation form) will be filled out by each patient.

The medical, anaesthetic and surgical care will not be changed. In the operating room, we will proceed with anaesthetic induction following a medical protocol according to the practice of our hospital (TCI Target Controlled Infusion or manual induction): the propofol infusion or injection is started with an initial effect-site concentration or dose and increased step by step until patients present the clinical en points defined as LOC (loss of consciousness, i.e. no response to a verbal command).

The effect-site concentration of propofol, induction time required for a loss of consciousness (LOC), and preoperative incidents will be recorded by an anaesthetist student nurse and will be recorded in a data book.

After surgery, we will record any secondary effect attributable to premedication.

The day after surgery, patients will be assessed with the EVAN-G questionnaire. Statistical analysis will be done in sub-groups with variance analysis. We will also do multivariate regression analysis according to the type of premedication, demographic data, preoperative variable and preoperative anxiety level. If the number of included patients allows it, we will do propensity score matching for premedication. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03603873
Study type	Observational
Source	CHU de Reims
Contact
Status	Completed
Phase
Start date	March 3, 2017
Completion date	May 24, 2017

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05777044` - The Effect of Hatha Yoga on Mental Health	N/A
Recruiting	`NCT04680611` - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Completed	`NCT04748367` - Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care	N/A
Completed	`NCT04512768` - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy	N/A
Recruiting	`NCT05563805` - Exploring Virtual Reality Adventure Training Exergaming	N/A
Completed	`NCT04579354` - Virtual Reality (VR) Tour to Reduce Preoperative Anxiety Before Anaesthesia	N/A
Completed	`NCT03457714` - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Completed	`NCT03535805` - Transdiagnostic, Cognitive and Behavioral Intervention for in School-aged Children With Emotional and Behavioral Disturbances	N/A
Recruiting	`NCT05956912` - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Active, not recruiting	`NCT05302167` - Molehill Mountain Feasibility Study.	N/A
Completed	`NCT05588622` - Meru Health Program for Cancer Patients With Depression and Anxiety	N/A
Completed	`NCT05881681` - A Mindfulness Approach to UA for Afro-descendants	N/A
Recruiting	`NCT04961112` - Evaluating the Efficacy of Cranial Electrotherapy Stimulation in Mitigating Anxiety-induced Cognitive Deficits	N/A
Recruiting	`NCT04612491` - Pre-operative Consultation on Patient Anxiety and First-time Mohs Micrographic Surgery
Completed	`NCT05980845` - The Effect Nature Sounds and Music on Hemodialysis Patients	N/A
Recruiting	`NCT05449002` - Digital Single Session Intervention for Youth Mental Health	N/A
Completed	`NCT05585749` - Virtual Reality Application on Pain Intensity and Anxiety Level in Endoscopy Patients	N/A
Terminated	`NCT03272555` - WILD 5 Wellness: A 30-Day Intervention	N/A
Recruiting	`NCT05997849` - Development of a Multiplatform Mental Health Mobile Tool	N/A
Active, not recruiting	`NCT03613155` - Assessment of Anxiety in Patients Treated by SMUR Toulouse and Receiving MEOPA as Part of Their Care

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Preoperative Anxiety Level, Premedications and General Anaesthetic Proceedings

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms