Inhaled Sevofluran vs Endovenous Propofol for Colonoscopy

Inhaled Sevofluran vs Endovenous Propofol for Sedation Maintenance in Patients Submitted to Colonoscopy

To compare the anesthetic efficacy of the inhalation versus intravenous technique for maintenance of sedation in patients undergoing endoscopy.

A longitudinal, randomized clinical study of 32 patients of both sexes ASA I-III, aged 18-80 years undergoing diagnostic colonoscopy, which was randomly divided into 2 groups. In both, intravenous induction with propofol (2-2.5 mg / kg) was performed, Group A remained sedated with propofol infusion (1-2 mg / kg / min); Group B by inhalation with sevoflurane at a concentration of 2 vol% through a nasal cannula with an oxygen flow.

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Drug: Propofol; Drug: Sevoflurane

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age between 18 and 80 years
• physical status I, II and III according to the criteria of the American Society of Anesthesiology (ASA)
• patients who are going to undergo diagnostic colonoscopies
• patients who signed the informed consent

Exclusion Criteria:

• Allergy or hypersensitivity to some of the reference drugs in the study
• patients with proven liver disease
• suspicion or confirmation of pregnancy
• antecedent or risk of malignant hyperthermia
• fasting less than 8 hours
• patients with psychic disorders or mental incapacity that make it difficult to understand their participation in the study
• patients who have acute illnesses that compromise their health for which the study cannot be performed

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group Propofol; propofol infusion	Drug: Propofol; after inicial bolus of propofol, remained sedated with propofol infusion (1-2 mg/kg/min)
EXPERIMENTAL: Group Sevoflurane; inhalation with sevoflurane	Drug: Sevoflurane; after inicial bolus of propofol, remained sedated by inhalation with sevoflurane at a concentration of 2 vol% through a nasal cannula with an oxygen flow.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Recovery Time	Every 5 minutes till a score of 10/10 achieved on Aldrete Score	30 min
Heart rate	heart rate per minute	During the colonoscopy - an estimated mean time of 20 minutes
Propofol dosage	propofol rescate bolus administered	During the colonoscopy - an estimated mean time of 20 minutes
arterial pressure	non invasive arterial pressure every 5 minutes	During the colonoscopy - an estimated mean time of 20 minutes
oxygen saturation	pulse oximetry	During the colonoscopy - an estimated mean time of 20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse reactions in patients	desaturation, laryngospasm	1 day (postoperative)
Endoscopist Satisfaction	Endoscopist Satisfaction scored from 1-10. Will be tested on a numerical scale from 0 (not satisfied at all) to 10 (fully satisfied)	60 min
Qualitatively assess patient comfort after sedation.	poor, regular or good	Up to 1 hour after completing the study.

Collaborators and Investigators

• Sponsor: Centro Medico Docente la Trinidad

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2016
• Primary Completion (ACTUAL): October 1, 2016
• Study Completion (ACTUAL): December 28, 2016

Study Registration Dates

• First Submitted: January 4, 2019
• First Submitted That Met QC Criteria: January 23, 2019
• First Posted (ACTUAL): January 28, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 28, 2019
• Last Update Submitted That Met QC Criteria: January 23, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: colonoscopy; sedation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Hypnotics and Sedatives; Anesthetics, Inhalation; Propofol; Sevoflurane
• Other Study ID Numbers: CMDLT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No