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

NCT ID: NCT04284644

Last Updated: 2020-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-01
• Study Completion Date: 2017-01-03

Brief 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.

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.

Conditions

Anesthesia; Anesthesia; Adverse Effect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group P

Patient received a dose of 1.5 mg/kg of Propofol slowly over 2 minutes for induction.

Group Type: EXPERIMENTAL

Induction using propofol

Intervention Type: DRUG

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.

Group S

Patient received 8% sevoflurane through sealed plastic facemask at 8 L/min flow of oxygen.

Group Type: EXPERIMENTAL

Induction using sevoflurane

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

Induction using propofol and sevoflurane

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Jordan

OTHER

Sponsor Role: lead

Responsible Party

omar ahmad ababneh

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Jordan University Hospital

Amman, , Jordan

Countries

Jordan

Other Identifiers

10/2016/4597

Identifier Type: -

Identifier Source: org_study_id