Co-induction Technique Compared to Standard Inhalational and Intravenous Induction Techniques

A Novel Co-induction Technique Compared to Standard Inhalational and Intravenous Induction Techniques: a Prospective Randomized Control Study

Co-induction technique refers to the use of a combination of medications to reach the desired therapeutic target. In the present study, the investigators examined the safety of a novel co-induction approach that relied on a simple timing and dosing alterations to the classical approaches of inhalational sevoflurane and propofol induction. The significance of this study is to find a reliable safe alternative method of induction that can provide optimal parameters,when compared to the classical methods of induction.

Study Overview

• Status: Completed
• Conditions: Anesthesia; Anesthesia; Adverse Effect
• Intervention / Treatment: Drug: Induction using propofol; Drug: Induction using sevoflurane; Drug: Induction using propofol and sevoflurane

Detailed Description

Co-induction technique refers to the use of a combination of medications to reach the desired therapeutic target. This technique is considered an approach that can be of a great benefit to patients with chronic medical illnesses and those who have moderate to high risk for general anaesthesia.

In the present study, the investigators examined the safety of a novel co-induction approach that relied on a simple timing and dosing alterations to the classical approaches of inhalational sevoflurane and propofol induction. The significance of this study is to find a reliable safe alternative method of induction that can provide optimal parameters,when compared to the classical methods of induction. The investigators evaluated the time needed for laryngeal mask airway (LMA) insertion, number of LMA insertion trials, succession of LMA insertion, adverse events related to the airway, respiratory and cardiovascular systems, haemodynamic stability and satisfaction scores of enrolled patients.

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Jordan
  • Amman, Jordan, 11942
    • Jordan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients with Age ≥ 65 years.
• American Society of Anaesthesiologists' (ASA) score II or III.
• minimally invasive endoscopic urological procedures.

Exclusion Criteria:

• patient refusal.
• Age < 65 years.
• family history of malignant hyperthermia.
• prolonged surgery that needed intubation.
• body mass index (BMI) > 35 kg/m2.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group P; Patient received a dose of 1.5 mg/kg of Propofol slowly over 2 minutes for induction.	Drug: Induction using propofol; Patients were given 1.5 mcg/Kg of fentanyl intravenously. two minutes after the fentanyl dose, a dose of 1.5 mg/kg of propofol slowly over 2 minutes.
Experimental: Group S; Patient received 8% sevoflurane through sealed plastic facemask at 8 L/min flow of oxygen.	Drug: Induction using sevoflurane; Patients were given 1.5 mcg/Kg of fentanyl intravenously. two minutes after the fentanyl dose, patient received 8% inhalational sevoflurane through sealed plastic face mask at 8 L/min flow of oxygen.
Experimental: Group C; Patient received 4% sevoflurane through sealed plastic facemask at 8 L/min flow of oxygen for 2 minutes, followed by a dose of 0.75 mg/kg of propofol given slowly.	Drug: Induction using propofol and sevoflurane; Patients were given 1.5 mcg/Kg of fentanyl intravenously. two minutes after the fentanyl dose, patient received 4% sevoflurane through sealed plastic face mask at 8 L/min flow of oxygen for 2 minutes, followed by a dose of 0.75 mg/kg of propofol given slowly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative respiratory adverse events	The investigators recorded the occurrence of transient apnea intraoperatively, in addition to laryngeal spasm, coughing, gagging and increased salivation. The study chart included the documentation these common adverse events, the timing of occurrence, and the intervention required to manage these events.	8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time for successful laryngeal mask airway insertion	The investigators assessed the time needed for LMA insertion. The timer was started upon giving the fentanyl, recording the time till successful insertion of laryngeal mask airway.	8 months
Blood pressure stability	The investigators recorded patients' blood pressure readings throughout the induction procedure.	8 months
Heart rate stability	The investigators recorded patients' heart rate throughout the induction procedure.	8 months
Changes in oxygen saturation	The investigators recorded patients' oxygen saturation throughout the induction procedure.	8 months

Collaborators and Investigators

• Sponsor: University of Jordan

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): January 2, 2017
• Study Completion (Actual): January 3, 2017

Study Registration Dates

• First Submitted: February 20, 2020
• First Submitted That Met QC Criteria: February 22, 2020
• First Posted (Actual): February 26, 2020

Study Record Updates

• Last Update Posted (Actual): February 26, 2020
• Last Update Submitted That Met QC Criteria: February 22, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Propofol; Sevoflurane; Laryngeal mask airway; General anesthesia; Co-induction
• 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: 10/2016/4597

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