Lavender Oil on Preoperative Anxiety and Sedation Requirement in General Anaesthesia

Preoperative Anxiety Clinical Trial

Official title:

Lavender Aromatherapy; Its Effect on Preoperative Anxiety and Propofol Requirement for Anaesthesia.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03460145
• Other study ID #: 37839
• Status: Completed
• Phase: N/A
• Start date: September 27, 2018
• Est. completion date: January 1, 2019

Study information

• Verified date: April 2018
• Source: Universiti Kebangsaan Malaysia Medical Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Assessment of how Lavender oil reduces preoperative anxiety and subsequently influences requirement of induction agents for general anesthesia.

Description:

This study aims to use aromatherapy (Lavender oil) to reduce Preoperative Anxiety among Female patients coming for elective surgeries under General Anesthesia.

As a consequence of that, the effect is also evaluated on how that influences the amount of intravenous sedation is required during induction for General Anesthesia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: January 1, 2019
• Est. primary completion date: December 10, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age 18-65

• Female

Exclusion Criteria:

• Patients on B-blockers and or antidepressants.

• BMI > 35kg/m2

• History of atopy

• History of alcoholism, substance abuse, smoking

• Patients with cancer

Related Conditions & MeSH terms

• Anxiety Disorders
• Preoperative Anxiety

Intervention

Other:
• Lavender Oil on Nasal Strip (Lx)
Usage of Aromatherapy for Preoperative Anxiety
• Strip without Lavender Oil (Px)
Strip without Lavender Oil (Px)

Drug:
• Propofol 1 % Injectable Suspension
Propofol 1% (10mg/mL)

Locations

Country	Name	City	State
Malaysia	University Kebangsaan Malaysia	Kuala Lumpur	Cheras

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Kebangsaan Malaysia Medical Centre

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. Visual Analog Scoring for Anxiety	Self reported anxiety score before and after inhalation of aromatherapy. 3 questions about preoperative anxiety are asked and scoring is done based on a 0-10cm scale (0= no anxiety, 10= agonizing anxiety). Cumulative scores for all 3 questions above 5 indicates preoperative anxiety.	1 day
Secondary	1. Amount of sedation used to achieve Loss of Consciousness	Induction for general anesthesia using Target control Infusion of Propofol 1% (10mg/mL) using the Schnider protocol, administered via a TIVA Agilia infusion pump to achieve a target plasma concentration of 4mcg/ml until loss of consciousness.	Less than 30minutes