Ketamine versus midazolam as an adjuvant to peribulbar block using single inferonasal injection in patients undergoing vitreoretinal surgery: A randomized controlled trial

Phase 2

Conditions: Peribulbar block in adult patients undergoing vitreoretinal surgeries..

Registration Number: IRCT20201220049777N2

Lead Sponsor: Research Institute of Ophthalmology

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 93

Inclusion Criteria

Patients undergoing vitreoretinal surgeries with axial length 20-29 mm
Adults (male or female) aged from 30 to 65 years old
American Society of Anesthesiologists (ASA) physical status I or II

Exclusion Criteria

Uncooperative patients
Patients who can’t lie flat for the duration of the procedure as those with skeletal problems or orthopneic patients
Patients with coagulopathy or using anticoagulant drugs

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The onset of globe akinesia. Timepoint: At 1, 3, 5 minutes after the block. Method of measurement: The 3-point scale.;The duration of analgesia. Timepoint: Time from the block till first analgesia required. Method of measurement: The 10-point Visual Analog Scale.

Secondary Outcome Measures

Name	Time	Method
The duration of motor block. Timepoint: At 1, 2, 3, 4, and 5 h postoperative. Method of measurement: Clinical assessment of regaining full movement.;The onset of lid akinesia. Timepoint: At 1, 2, and 3 min after the block. Method of measurement: The 3-point scale.;The onset of corneal anesthesia. Timepoint: At 15 seconds intervals for one minute after the block. Method of measurement: Clinical assessment using a cotton pad.;The vital data (blood pressure, oxygen saturation, and pulse rate). Timepoint: Before giving the block (baseline) and then every 5 minutes after the block. Method of measurement: Clinical assessment.