Evaluation of Anxiolysis and Pain Associated With Retrobulbar Eye Block for Cataract Surgery : Melatonin Versus Gabapentin

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01200641
• Date of registration: 10/09/2010
• Primary sponsor: Qazvin University Of Medical Sciences
• Public title: Evaluation of Anxiolysis and Pain Associated With Retrobulbar Eye Block for Cataract Surgery : Melatonin Versus Gabapentin
• Scientific title: Evaluation of Anxiolysis and Pain Associated With Retrobulbar Eye Block for Cataract Surgery : Melatonin Versus Gabapentin ( A Randomized, Double-blind, Placebo-controlled Study)
• Date of first enrolment: September 2010
• Target sample size: 90
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01200641
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Countries of recruitment

Iran, Islamic Republic of

Key inclusion & exclusion criteria

Inclusion Criteria:

- patients who were aged 25 years or older, American Society of Anesthesiologists (ASA)
physical status I-III

Exclusion Criteria:

- Patients with ASA status IV

- history of hepatic or renal disease, confusion, dementia

- communication difficulty resulting from deafness or language barrier

- chronic use of narcotics, barbiturates or psychotropic medications

- history of allergy or contraindications to any of the study drugs

- visual impairment of the non operative eye

- weight < 40 kg or > 100 kg



Age minimum: 35 Years
Age maximum: 85 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Anxiety

Pain

Intervention(s)

Drug: Gabapentin

Drug: Melatonin

Drug: placebo

Primary Outcome(s)

anxiety will be assessed by verbal anxiety score (VAS) of 10 (0 = completely calm and 10 = the worst possible anxiety) [Time Frame: 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)]

anxiety will be assessed by verbal anxiety score (VAS) of 10 (0 = completely calm and 10 = the worst possible anxiety) [Time Frame: one minute after retrobulbar block placement]

anxiety will be assessed by verbal anxiety score (VAS) of 10 (0 = completely calm and 10 = the worst possible anxiety) [Time Frame: postoperatively before discharging the patient from the recovery room]

pain will be assessed by verbal pain score (VPS) of 10 (0 = no pain and 10 = worst pain imaginable) [Time Frame: 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)]

pain will be assessed by verbal pain score (VPS) of 10 (0 = no pain and 10 = worst pain imaginable) [Time Frame: one minute after retrobulbar block placement]

pain will be assessed by verbal pain score (VPS) of 10 (0 = no pain and 10 = worst pain imaginable) [Time Frame: postoperatively before discharging the patient from the recovery room]

Secondary Outcome(s)

heart rate will be assessed by echocardiogram monitoring [Time Frame: before premedication]

heart rate will be assessed by echocardiogram monitoring [Time Frame: during the operation period(five minutes after beginning of surgery]

heart rate will be assessed by echocardiogram monitoring [Time Frame: ninety minutes after premedication, on arrival in the operating room]

heart rate will be assessed by echocardiogram monitoring [Time Frame: one minute after retrobulbar block placement]

heart rate will be assessed by echocardiogram monitoring [Time Frame: postoperatively before discharge the patient from the recovery room]

mean arterial blood pressure will be assessed by noninvasive automatic blood pressure measurement [Time Frame: before premedication]

mean arterial blood pressure will be assessed by noninvasive automatic blood pressure measurement [Time Frame: during the operation period(five minutes after beginning of surgery]

mean arterial blood pressure will be assessed by noninvasive automatic blood pressure measurement [Time Frame: ninety minutes after premedication, on arrival in the operating room]

mean arterial blood pressure will be assessed by noninvasive automatic blood pressure measurement [Time Frame: one minute after retrobulbar block placement]

mean arterial blood pressure will be assessed by noninvasive automatic blood pressure measurement [Time Frame: postoperatively before discharge the patient from the recovery room]

satisfaction of surgeon according to three degree scale as very bad, moderate, good will be assessed [Time Frame: at the end of surgery]

satisfaction of surgeon according to three degree scale as very bad, moderate, good will be assessed [Time Frame: one minute after retrobulbar block placement]

Secondary ID(s)

ACTRN12610000727044

Source(s) of Monetary Support

Please refer to primary and secondary sponsors