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

NCT04284644 | Completed

• 1 other identifier: 10/2016/4597
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Anesthesia; Adverse Effect

Keywords

General anesthesia; Propofol; Sevoflurane; Co-induction; Laryngeal mask airway

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Time for successful laryngeal mask airway insertion

  8 months

• Blood pressure stability

  8 months

• Heart rate stability

  8 months

• Changes in oxygen saturation

  8 months

Study Arms (3)

Group P

EXPERIMENTAL

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

Drug: Induction using propofol

Group S

EXPERIMENTAL

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

Drug: Induction using sevoflurane

Group C

EXPERIMENTAL

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

Interventions

Induction using propofol 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 P

Induction using sevoflurane 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 S

Induction using propofol and sevoflurane 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.

Group C

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Jordan: lead

Study Sites (1)

Jordan University Hospital

Amman, 11942, Jordan

Location

MeSH Terms

Interventions

Sevoflurane

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 20, 2020
• First Posted: February 26, 2020
• Study Start: May 1, 2016
• Primary Completion: January 2, 2017
• Study Completion: January 3, 2017
• Last Updated: February 26, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)