Lavender Oil on Preoperative Anxiety and Sedation Requirement in General Anaesthesia

Not Applicable

Completed

• Conditions: Preoperative Anxiety
• Interventions: Other: Strip without Lavender Oil (Px); Other: Lavender Oil on Nasal Strip (Lx); Drug: Propofol 1 % Injectable Suspension

• Registration Number: NCT03460145
• Lead Sponsor: Universiti Kebangsaan Malaysia Medical Centre

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2018-01-24
• Study First Submitted QC: 2018-03-08
• Study First Posted: 2018-03-09
• Status Verified: 2018-04
• Study Start: 2018-09-27
• Primary Completion: 2018-12-10
• Study Completion: 2019-01-01
• Last Update Submitted: 2019-05-19
• Last Update Posted: 2019-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Strip without Lavender Oil (Px)	Strip without Lavender Oil (Px)	Application of Nasal strip without essential oil, acting as placebo. VAS- Anxiety scores pre and post placebo.
Strip without Lavender Oil (Px)	Propofol 1 % Injectable Suspension	Application of Nasal strip without essential oil, acting as placebo. VAS- Anxiety scores pre and post placebo.
Strip with Lavender Oil (Lx)	Lavender Oil on Nasal Strip (Lx)	Application of Nasal Strip with essential oil (Lavender), 20minutes before induction. VAS- Anxiety scores pre and post inhalation.
Strip with Lavender Oil (Lx)	Propofol 1 % Injectable Suspension	Application of Nasal Strip with essential oil (Lavender), 20minutes before induction. VAS- Anxiety scores pre and post inhalation.

Primary Outcome Measures

Name	Time	Method
1. Visual Analog Scoring for Anxiety	1 day	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.

Secondary Outcome Measures

Name	Time	Method
1. Amount of sedation used to achieve Loss of Consciousness	Less than 30minutes	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.

Trial Locations

Locations (1)

University Kebangsaan Malaysia; 🇲🇾 Kuala Lumpur, Cheras, Malaysia