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

Sponsor
University of Jordan (Other)
Overall Status
Completed
CT.gov ID
NCT04284644
Collaborator
(none)
105
1
3
8.1
12.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Induction using propofol
  • Drug: Induction using sevoflurane
  • Drug: Induction using propofol and sevoflurane
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
105 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
A Novel Co-induction Technique Compared to Standard Inhalational and Intravenous Induction Techniques: a Prospective Randomized Control Study
Actual Study Start Date :
May 1, 2016
Actual Primary Completion Date :
Jan 2, 2017
Actual Study Completion Date :
Jan 3, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Intraoperative respiratory adverse events [8 months]

    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.

Secondary Outcome Measures

  1. Time for successful laryngeal mask airway insertion [8 months]

    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.

  2. Blood pressure stability [8 months]

    The investigators recorded patients' blood pressure readings throughout the induction procedure.

  3. Heart rate stability [8 months]

    The investigators recorded patients' heart rate throughout the induction procedure.

  4. Changes in oxygen saturation [8 months]

    The investigators recorded patients' oxygen saturation throughout the induction procedure.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jordan University Hospital Amman Jordan 11942

Sponsors and Collaborators

  • University of Jordan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
omar ahmad ababneh, Principal Investigator, University of Jordan
ClinicalTrials.gov Identifier:
NCT04284644
Other Study ID Numbers:
  • 10/2016/4597
First Posted:
Feb 26, 2020
Last Update Posted:
Feb 26, 2020
Last Verified:
Feb 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by omar ahmad ababneh, Principal Investigator, University of Jordan
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 26, 2020