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

NCT01200641 | Completed Phase 1 DMC

• 1 other identifier: ACTRN12610000727044
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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 .The investigators 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. The investigators 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 0.5microgram/kg as needed.

Conditions

Anxiety; Pain

Keywords

melatonin; gabapentin; anxiety; pain; retrobulbar block

Outcome Measures

Primary Outcomes (6)

• 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

• pain will be assessed by verbal pain score (VPS) of 10 (0 = no pain and 10 = worst pain imaginable)

  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)

  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)

  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)

  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)

  postoperatively before discharging the patient from the recovery room

Secondary Outcomes (12)

• mean arterial blood pressure will be assessed by noninvasive automatic blood pressure measurement

  before premedication

• mean arterial blood pressure will be assessed by noninvasive automatic blood pressure measurement

  ninety minutes after premedication, on arrival in the operating room

• mean arterial blood pressure will be assessed by noninvasive automatic blood pressure measurement

  one minute after retrobulbar block placement

• mean arterial blood pressure will be assessed by noninvasive automatic blood pressure measurement

  during the operation period(five minutes after beginning of surgery

• mean arterial blood pressure will be assessed by noninvasive automatic blood pressure measurement

  postoperatively before discharge the patient from the recovery room

Study Arms (3)

melatonin

ACTIVE COMPARATOR

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).

Drug: Melatonin

gabapentin

ACTIVE COMPARATOR

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).

Drug: Gabapentin

placebo

PLACEBO COMPARATOR

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).

Drug: placebo

Interventions

Melatonin DRUG

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).

melatonin

Gabapentin DRUG

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).

gabapentin

placebo DRUG

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).

placebo

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qazvin University Of Medical Sciences: lead

Study Sites (1)

Qazvin university of medical science

Qazvin, Qazvin Province, 34197/59811, Iran

Location

MeSH Terms

Conditions

Anxiety Disorders; Pain

Interventions

Melatonin; Gabapentin

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Qazvin University Of Medical Sciences

Study Record Dates

• First Submitted: September 10, 2010
• First Posted: September 13, 2010
• Study Start: September 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: January 1, 2011
• Last Updated: October 11, 2012

Record last verified: 2012-10

Locations

IR (1)