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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04284644
• Other study ID #: 10/2016/4597
• Status: Completed
• Phase: N/A
• Start date: May 1, 2016
• Est. completion date: January 3, 2017

Study information

• Verified date: February 2020
• Source: University of Jordan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: January 3, 2017
• Est. primary completion date: January 2, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Anesthesia; Adverse Effect

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Jordan	Jordan University Hospital	Amman

Sponsors (1)

Lead Sponsor	Collaborator
University of Jordan

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Blood pressure stability	The investigators recorded patients' blood pressure readings throughout the induction procedure.	8 months
Secondary	Heart rate stability	The investigators recorded patients' heart rate throughout the induction procedure.	8 months
Secondary	Changes in oxygen saturation	The investigators recorded patients' oxygen saturation throughout the induction procedure.	8 months