Propofol Administered by Gastroenterologists by Target Controlled Infusion Pump During Endoscopy

Sedation Clinical Trial

— Propofol TCI  

Official title:

Propofol Administered by Gastroenterologists by Target Controlled Infusion Pump During Endoscopy: a Randomized Double Blind Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02062177
• Other study ID #: Propofol TCI endoscopy
• Status: Completed
• Phase: Phase 4
• First received: February 3, 2014
• Last updated: August 29, 2014
• Start date: February 2014
• Est. completion date: May 2014

Study information

• Verified date: August 2014
• Source: Università Vita-Salute San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Many studies address safety of non-anesthesiologist propofol sedation (NAPS) for gastrointestinal endoscopy. Target Controlled Infusion (TCI) is a sophisticated tool for providing optimal sedation regimen and avoiding under or oversedation. The objective of the study is to compare standard moderate sedation during upper endoscopy and colonoscopy versus propofol NAPS.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: May 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age < 18 years

• American Society of Anesthesiologists risk I-II

• patients undergoing to Gastroscopy or Colonoscopy

Exclusion Criteria:

• significant systemic disease

• allergic reactions to any of study drugs

• chronic use of opioids or psychiatric disorders

• pregnancy

• Mallampati score > 2

• age < 18 years

Study Design

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

Related Conditions & MeSH terms

• Endoscopy
• Sedation

Intervention

Drug:
• Propofol
70 patients (35 upper endoscopy - 35 colonoscopy) are sedated with propofol TCI (Target Controlled Infusion) pump (concentration 1.2-1.6 mcg/ml).
• Midazolam
70 patients (35 upper endoscopy - 35 colonoscopy) in group midazolam are sedated with midazolam 0.04 mg/Kg if aged < 70, 0.03 mg/Kg if aged > 70.

Locations

Country	Name	City	State
Italy	San Raffaele Hospital	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Università Vita-Salute San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endoscopist's Satisfaction (Visual Analog Scale) About Sedation	Visual Analog Scale from 0 to100 (0=dissatisfaction - 100=complete satisfaction) will be used to assess the technical difficulty of examination and the satisfaction with sedation of patient experienced by endoscopist	at the end of the exam	Yes
Primary	Patient's Satisfaction (Visual Analog Scale) About Sedation Before Discharge	When completely awake, patients will be asked to rate the degree of pain/discomfort and the degree of satisfaction about quality of sedation from 0 to100 (0=dissatisfaction - 100=complete satisfaction)	before discharge	Yes
Primary	Patient's Satisfaction (Visual Analog Scale) About Sedation 24-72 Hours After Procedure	Patients will be contacted by telephone 24-72 hours after discharge and asked about their satisfaction about the quality of sedation, rated on a verbal rating scale, from 0 to 100 (0=dissatisfaction; 100=complete satisfaction)	at 24-72 hours after procedure	Yes
Secondary	Time (Minutes) to Dischargeability of Patient From Endoscopic Unit	After endoscopy, patients will be transferred to recovery area and evaluated every 5 minutes until they will be ready to be discharged from the Endoscopy Unit. Recovery will be assessed using the Modified Aldrete Scoring System; patients will be considered fit for discharge with a Modified Aldrete Scoring System score of 18 or more, stable vital signs and without nausea, vomiting, or itching.	one day	Yes
Secondary	Number of Participants With Adverse Events as a Measure of Safety	Number of patients with adverse events (hypotension, bradycardia, hypoxemia,...)	one day	Yes