Clinical Trials Logo

Clinical Trial Summary

Many studies address safety and effectiveness of non-anesthesiologist propofol sedation (NAPS) for GI endoscopy. Target Controlled Infusion (TCI) is a sophisticated tool for providing optimal sedation regimen and avoiding under or oversedation.

This randomized double blind controlled study compares standard moderate sedation level of sedation (group S) during upper endoscopy (EGD) and colonoscopy (CS) versus propofol NAPS (group P).


Clinical Trial Description

70 CS and 70 EGD ASA I-II patients were studied. In group S (n=70) we administered fentanyl (1μg/kg) + midazolam (0.04-0.03 mg/kg) for CS and midazolam (0.04-0.03 mg/kg) for EGDS and in group P (n=70) fentanyl 1µg/Kg + propofol TCI 1.2-1.6 μg/ml for CS and propofol TCI 1.2-1.6 μg/ml for EGD. Vital parameters and Observer's Assessment of Alertness and Sedation Scale (OAA/S) were monitored throughout the study. Endoscopist's and patient's satisfactions were measured after procedure and 24-72 h later by visual analog scale (VAS). ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01941888
Study type Interventional
Source Ospedale San Raffaele
Contact
Status Completed
Phase Phase 4
Start date May 2012
Completion date March 2013

See also
  Status Clinical Trial Phase
Completed NCT04235894 - An Observer Rating Scale of Facial Expression Can Predict Dreaming in Propofol Anesthesia
Completed NCT05103735 - Propofol-remifentanyl Versus Dexmedetomidine in Awake Craniotomy: Impact on Electroclinical Seizure Activity
Recruiting NCT06210061 - Propofol-Fentanyl-Dexmedetomidine and Propofol-Fentanyl-Sevoflurane Anesthesia for Major Spine Surgery Under Somato Sensory- and Motor- Evoked Potential Monitoring N/A
Completed NCT06098196 - Effects of Aminophylline Bolus on TCI (Target Controlled Infusion) Concentrations at Return of Responsiveness
Completed NCT06098209 - Dexmedetomidine and Propofol in Mechanically Ventilated Patients by Using Salivary Alpha-amylase as a Stress Marker N/A
Completed NCT04805775 - Desflurane and Postoperative Sleep Quality in Patients Undergoing Elective Breast Surgery N/A
Recruiting NCT05971121 - Comparing Ciprofol and Propofol for Sedation in Hypotensive ICU Patients: a Single Center Prospective Cohort Study
Recruiting NCT05533567 - Electroencephalographic Profiles During General Anesthesia: a Comparative Study of Remimazolam and Propofol N/A
Recruiting NCT05533580 - Differential Effects of Remimazolam and Propofol on Dynamic Cerebral Autoregulation During General Anesthesia N/A
Completed NCT06243822 - Ketamine Versus Propofol as ICU Sedation Phase 4
Completed NCT03741361 - The Impact of Anxiety or Depression on the Sedative Concentration of Propofol
Recruiting NCT06403852 - Investigating Near-Threshold Perception During Anesthetic Sedation Phase 2
Not yet recruiting NCT06386965 - Sevoflurane Versus Propofol: Effect on Stress Response
Recruiting NCT02687568 - Values of Enhanced Monitoring by EEG Recording (Narcotrend) for Sedation in Colonoscopy N/A
Completed NCT04123249 - The Effects of Intravenous Anesthetics and Inhaled Anesthetics on Patients' Postoperative Sleep N/A
Recruiting NCT05352685 - Effects of Propofol on Auditory Event-related Potentials and Brain Functional Connectivity in Patients With Supratentorial Glioma N/A
Completed NCT05800288 - Effect of Midazolam Bolus on Eleveld and Schnider TCI (Target Controlled Infusion) Models
Recruiting NCT04729478 - Comparison Between Natural Sleep Endoscopy and Drug-induced Sleep Endoscopy in Patients With Obstructive Sleep Apnea N/A
Completed NCT04394897 - Total Intravenous Anesthesia With Remifentanil-propofol Admixture
Completed NCT05757063 - Impact of Two Different Types of Sedation on ICEB N/A