Opioid Free Versus Opioid Balanced Anesthesia in Ophthalmic Surgery

University of Indonesia (UI)

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Anesthesia, Endotracheal; Anesthesia and Analgesia

Treatments: Drug: Fentanyl; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT06382831

IndonesiaU240201

Details and patient eligibility

About

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

Enrollment: 104 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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104 participants in 2 patient groups

Control

Active Comparator group

Treatment:

Drug: Fentanyl

Opioid free anesthesia

Experimental group

Treatment:

Drug: Dexmedetomidine