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Trial registered on ANZCTR


Registration number
ACTRN12610000727044
Ethics application status
Approved
Date submitted
27/08/2010
Date registered
1/09/2010
Date last updated
15/02/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of Anxiolysis and Pain Associated with Retrobulbar Eye Block for Cataract Surgery : Melatonin versus Gabapentin ( A randomized, double-blind, placebo-controlled study)
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)
Secondary ID [1] 252586 0
nil
Universal Trial Number (UTN)
U1111-1116-7564
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pain during performance retrobulbar block and cataract surgery 258080 0
anxiety during performance retrobulbar block and cataract surgery 258081 0
Tolerance of retrobulbar injection
and comfort during the surgical procedure 258082 0
Condition category
Condition code
Anaesthesiology 258256 258256 0 0
Anaesthetics
Eye 258270 258270 0 0
Diseases / disorders of the eye
Surgery 258280 258280 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ninety patients scheduled for cataract surgery by phacoemulsification were randomly allocated to three study groups to receive melatonin 6

mg (Group M, n = 30) , gabapentin 600mg(GroupG, n = 30)or placebo(GroupP, n=30) orally 90 minutes before retrobulbar injection( for all of three groups).
Intervention code [1] 257109 0
Prevention
Intervention code [2] 257110 0
Treatment: Drugs
Comparator / control treatment
received placebo tab (without active ingredient and Taste which is prepared by Pharmacist ) orally
Control group
Placebo

Outcomes
Primary outcome [1] 259097 0
pain will be assessed by verbal pain score (VPS) of 10 (0 = no pain and 10 = worst pain imaginable)
Timepoint [1] 259097 0
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
Primary outcome [2] 259098 0
anxiety will be assessed by verbal anxiety score (VAS) of 10 (0 = completely calm and 10 = the worst possible anxiety)
Timepoint [2] 259098 0
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)
Secondary outcome [1] 265400 0
mean arterial blood pressure will be assessed by noninvasive automatic blood pressure measurement
Timepoint [1] 265400 0
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(five minutes after beginning of surgery) (T4) and postoperatively before discharge the patient from the recovery room (T5)
Secondary outcome [2] 265401 0
heart rate will be assessed by echocardiogram monitoring
Timepoint [2] 265401 0
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(five minutes after beginning of surgery) (T4) and postoperatively before discharge the patient from the recovery room (T5)
Secondary outcome [3] 265402 0
satisfaction of surgeon according to three degree scale as very bad, moderate, good will be assessed
Timepoint [3] 265402 0
the surgeon was asked about average level of his satisfaction during performance of block and operation period one minute after retrobulbar block placement and at the end of surgery

Eligibility
Key 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
Minimum age
25 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Enrollment is decided and permission of the patient is obtained by the same anesthesiologist during preoperative rounding,.This is a double blinded clinical trial, with blinding of both the patient and the administrating practitioner to the anesthetic type. Allocation will be managed by a Resident external to the project.study drugs will be give by nurse that is non-involved in this project
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization was based on computer-generated codes
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/09/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment outside Australia
Country [1] 2842 0
Iran, Islamic Republic Of
State/province [1] 2842 0
qazvin

Funding & Sponsors
Funding source category [1] 257555 0
Self funded/Unfunded
Name [1] 257555 0
marzieh khezri
Country [1] 257555 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Qazvin university of medical science
Address
shahid bahonar,Ave3419759811 Qazvin ,Iran
postal code:34197/59811
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 256776 0
Hospital
Name [1] 256776 0
Booali hospital
Address [1] 256776 0
booali street,Qazvin ,Iran
postal code:34137-86165
Country [1] 256776 0
Iran, Islamic Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259578 0
Qazvin Medical University Science
Ethics committee address [1] 259578 0
shahid bahonar,Ave3419759811 Qazvin ,Iran postal code:34197/59811
Ethics committee country [1] 259578 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 259578 0
25/07/2010
Approval date [1] 259578 0
23/08/2010
Ethics approval number [1] 259578 0
d/20/1718

Summary
Brief summary
Principle goals of sedation for eye surgery are to provide patient comfort and to allow the patient to stay calm during both retrobulbar injection and surgery. Insufficient sedation may not prevent the patient from moving during retrobulbar injection, whereas very deep sedation may result in respiratory complications during surgery .We compared the effect of melatonin and gabapentin on the hemodynamic parameters, sedation ,anxiety, and pain and satisfaction profile in cataract surgery. After approval by the Hospital Evaluation Committee of Scientific Studies for ethical purpose and written informed consent, ninety patients scheduled for cataract surgery by phacoemulsification were randomly allocated to three study groups to receive melatonin 6 mg (Group M, n = 30) , gabapentin 600mg(GroupG, n = 30)or placebo(GroupP, n=30) 90 minutes before retrobulbar injection. . Hemodynamic parameters ,anxiety, sedation score , and pain during block and surgery, satisfaction of surgeon were assessed. . At the preoperative visit verbal pain score (VPS) of 10 (0 = no pain and 10 = worst pain imaginable) and verbal anxiety score (VAS) ranging from 0 to 10 (0= completely calm, 10 = the worst possible anxiety) were explained to patients. Then a 20 gauge cannula was inserted into one of the two hands. Patients were monitored with electrocardiogram, noninvasive measurement of blood pressure, and pulse oximetry (SPO2). Retrobulbar nerve block was performed by the same ophthalmic surgeon who was unaware of group allocation with 1.5 ml of solution that prepared by nurse( lidocaine 2%and 0.5 ml bupivacaine) via the percutaneous route with a 25 G, 38 mm Atkinson needle (John Weiss & Son Limited, Milton Keynes,England), at inferotemporal site. No patient received an additional facial nerve block. We assessed the pain immediately after block and surgery. Anxiety score and pain score was recorded in each patient 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) and postoperatively before discharging the patient from the recovery room (T5) .At the end of surgery, the patients were asked about average level of their anxiety and pain during the operation period according to the VAS and VPS explained to them before premedication.`. The surgeon was also asked to verbally rate their level of satisfaction according to three degree scale as “very bad, , moderate, good after the operation. The sedation level of patients during performance of block was assessed as Sedation scores were obtained on a 3 point scale with 0 =movements of the head, arms and trunk ,1 =slightly movement of arms,2=slightly change in face,3=complete calm. If sedation was inadequate, fentanyl could be given 0.25microgram/kg as needed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31584 0
Address 31584 0
Country 31584 0
Phone 31584 0
Fax 31584 0
Email 31584 0
Contact person for public queries
Name 14831 0
Marzieh Beigom Khezri
Address 14831 0
Marzieh Beigom Khezri, , Department of Anesthesiology , Qazvin University of Medical Science Iran ,qazvin-boulvar bahonar
postal code:34188 99578
Country 14831 0
Iran, Islamic Republic Of
Phone 14831 0
+98-912-3811009
Fax 14831 0
+98-281-2236378
Email 14831 0
[email protected]
Contact person for scientific queries
Name 5759 0
Marzieh Beigom Khezri
Address 5759 0
Marzieh Beigom Khezri, , Department of Anesthesiology , Qazvin University of Medical Science Iran ,qazvin-boulvar bahonar
postal code:34188 99578
Country 5759 0
Iran, Islamic Republic Of
Phone 5759 0
+98-912-3811009
Fax 5759 0
+98-281-2236378
Email 5759 0
[email protected]

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