Inhaled Sevofluran vs Endovenous Propofol for Colonoscopy

NCT03818048 | Completed DMC

• 1 other identifier: CMDLT
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anesthesia

Keywords

sedation; colonoscopy

Outcome Measures

Primary Outcomes (5)

• Heart rate

  heart rate per minute

  During the colonoscopy - an estimated mean time of 20 minutes

• The Recovery Time

  Every 5 minutes till a score of 10/10 achieved on Aldrete Score

  30 min

• 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 Outcomes (3)

• adverse reactions in patients

  1 day (postoperative)

• Endoscopist Satisfaction

  60 min

• Qualitatively assess patient comfort after sedation.

  Up to 1 hour after completing the study.

Study Arms (2)

Group Propofol

EXPERIMENTAL

propofol infusion

Drug: Propofol

Group Sevoflurane

EXPERIMENTAL

inhalation with sevoflurane

Drug: Sevoflurane

Interventions

Propofol DRUG

after inicial bolus of propofol, remained sedated with propofol infusion (1-2 mg/kg/min)

Group Propofol

Sevoflurane DRUG

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.

Group Sevoflurane

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro Medico Docente la Trinidad: lead

MeSH Terms

Interventions

Propofol; Sevoflurane

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, anesthesiologist.

Study Record Dates

• First Submitted: January 4, 2019
• First Posted: January 28, 2019
• Study Start: January 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: December 28, 2016
• Last Updated: January 28, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share