Inhaled Sevofluran vs Endovenous Propofol for Colonoscopy

Not Applicable

Completed

• Conditions: Anesthesia
• Interventions: Drug: Propofol; Drug: Sevoflurane

• Registration Number: NCT03818048
• Lead Sponsor: Centro Medico Docente la Trinidad

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2016-10-01
• Study Completion: 2016-12-28
• Status Verified: 2019-01
• Study First Submitted: 2019-01-04
• Study First Submitted QC: 2019-01-23
• Last Update Submitted: 2019-01-23
• Study First Posted: 2019-01-28
• Last Update Posted: 2019-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Propofol	Propofol	propofol infusion
Group Sevoflurane	Sevoflurane	inhalation with sevoflurane

Primary Outcome Measures

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

Secondary Outcome Measures

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