Opioid Free Versus Opioid Balanced Anesthesia in Ophthalmic Surgery

Anesthesia and Analgesia Clinical Trial

Official title:

Comparing Opioid Free Versus Opioid Balanced Anesthesia in Ophthalmic Surgery: a Single Centre Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06382831
• Other study ID #: IndonesiaU240201
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: June 1, 2024
• Est. completion date: October 1, 2024

Study information

• Verified date: April 2024
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Anesthesia without the use of opioid (Opioid free anesthesia) is an alternative to conventional opioid balanced anesthesia, with less post operative nausea and vomiting, and comparable analgesia. This study aim to compare the effect of opioid free versus opioid balanced anesthesia in ophthalmology surgery

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 104
• Est. completion date: October 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Physical status of ASA 1-2

• Undergo elective ophthalmology surgery under general anesthesia with laryngeal mask insertion

• BMI 17.5-34.9

Exclusion Criteria:

• Allergy to study drugs

• Baseline heart rate < 70 beat per minute or systolic blood pressure < 100 mmHg

• Will undergo regional block

• Operation lasting for > 4 hours or < 90 minutes

• Consumes opioid routinely prior to operation

Related Conditions & MeSH terms

• Anesthesia and Analgesia
• Anesthesia, Endotracheal

Intervention

Drug:
• Dexmedetomidine
Opioid free anesthesia
• Fentanyl
Control given Opioid balanced anesthesia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative nausea and vomiting (PONV)	Incidence of PONV	24 hours
Primary	Pain score	Pain score assessed with numerical rating scale (0-10) where higher value corresponds to more pain experienced by the patient	24 hours
Primary	Time to laryngeal mask exertion	Measured from the last surgical knot to LMA exertion	Intraoperative
Primary	Adverse effect	Severe changes in hemodynamics, including severe bradycardia, tachycardia, hypotension, hypertension, desaturation	24 hours