Evaluation of Anxiolysis and Pain Associated with Retrobulbar Eye Block for Cataract Surgery : Melatonin versus Gabapentin ( A randomized, double-blind, placebo-controlled study)

Phase 1

Recruiting

• Conditions: pain during performance retrobulbar block and cataract surgery; anxiety during performance retrobulbar block and cataract surgery; Tolerance of retrobulbar injectionand comfort during the surgical procedure; Tolerance of retrobulbar injection; and comfort during the surgical procedure; Anaesthesiology - Anaesthetics; Eye - Diseases / disorders of the eye; Surgery - Surgical techniques

• Registration Number: ACTRN12610000727044
• Lead Sponsor: Qazvin university of medical science

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-09-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

patients who were aged 25 years or older, American
Society of Anesthesiologists (ASA) physical status I-III scheduled to undergo retrobulbar eye block for cataract surgery

Exclusion Criteria

Patients with ASA status IV, history of hepatic or renal disease, confusion, dementia, or
communication difficulty resulting from deafness or
language barrier, chronic use of narcotics, barbiturates or psychotropic medications , allergy or contraindications to any of the study drugs , visual impairment of the
non operative eye and weight < 40 kg or > 100 kg

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pain will be assessed by verbal pain score (VPS) of 10 (0 = no pain and 10 = worst pain imaginable)[one minute after retrobulbar block placement,during the operation period(At the end of surgery the patients were asked about average level of their pain during the operation period according to the VPS explained to them before premedication) , and postoperatively before discharging the patient from the recovery room];anxiety will be assessed by verbal anxiety score (VAS) of 10 (0 = completely calm and 10 = the worst possible anxiety)[before premedication (T1), ninety minutes after premedication, on arrival in the operating room (T2), one minute after retrobulbar block placement (T3)during the operation period, (T4)[At the end of surgery, the patients were asked about average level of their anxiety during the operation period according to the VAS explained to them before premedication ]and postoperatively before discharge of the patient from the recovery room (T5)]