Inhaled Sevofluran vs Endovenous Propofol for Colonoscopy

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03818048
• Other study ID #: CMDLT
• Status: Completed
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: December 28, 2016

Study information

• Verified date: January 2019
• Source: Centro Medico Docente la Trinidad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 28, 2016
• Est. primary completion date: October 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Propofol
after inicial bolus of propofol, remained sedated with propofol infusion (1-2 mg/kg/min)
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centro Medico Docente la Trinidad

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate	heart rate per minute	During the colonoscopy - an estimated mean time of 20 minutes
Primary	The Recovery Time	Every 5 minutes till a score of 10/10 achieved on Aldrete Score	30 min
Primary	Propofol dosage	propofol rescate bolus administered	During the colonoscopy - an estimated mean time of 20 minutes
Primary	arterial pressure	non invasive arterial pressure every 5 minutes	During the colonoscopy - an estimated mean time of 20 minutes
Primary	oxygen saturation	pulse oximetry	During the colonoscopy - an estimated mean time of 20 minutes
Secondary	adverse reactions in patients	desaturation, laryngospasm	1 day (postoperative)
Secondary	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
Secondary	Qualitatively assess patient comfort after sedation.	poor, regular or good	Up to 1 hour after completing the study.