Inhaled Sevofluran vs Endovenous Propofol for Colonoscopy

Study Overview
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Brief Summary
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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.

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

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: Propofol
* Drug: Sevoflurane


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group Propofol<br>propofol infusion | Drug: Propofol<br>* after inicial bolus of propofol, remained sedated with propofol infusion (1-2 mg/kg/min)<br>|
| Experimental: Group Sevoflurane<br>inhalation with sevoflurane | Drug: Sevoflurane<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sedation, colonoscopy