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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
marzieh beigom khezri, Qazvin University Of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01200641
First received: September 10, 2010
Last updated: October 10, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Anxiety
Pain
Drug: Melatonin
Drug: Gabapentin
Drug: placebo
Phase 1
Phase 2

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
Official Title: Evaluation of Anxiolysis and Pain Associated With Retrobulbar Eye Block for Cataract Surgery : Melatonin Versus Gabapentin ( A Randomized, Double-blind, Placebo-controlled Study)

Resource links provided by NLM:


Further study details as provided by Qazvin University Of Medical Sciences:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • mean arterial blood pressure will be assessed by noninvasive automatic blood pressure measurement [ Time Frame: before premedication ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • mean arterial blood pressure will be assessed by noninvasive automatic blood pressure measurement [ Time Frame: one minute after retrobulbar block placement ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • mean arterial blood pressure will be assessed by noninvasive automatic blood pressure measurement [ Time Frame: postoperatively before discharge the patient from the recovery room ] [ Designated as safety issue: Yes ]
  • heart rate will be assessed by echocardiogram monitoring [ Time Frame: before premedication ] [ Designated as safety issue: Yes ]
  • heart rate will be assessed by echocardiogram monitoring [ Time Frame: ninety minutes after premedication, on arrival in the operating room ] [ Designated as safety issue: Yes ]
  • heart rate will be assessed by echocardiogram monitoring [ Time Frame: one minute after retrobulbar block placement ] [ Designated as safety issue: Yes ]
  • heart rate will be assessed by echocardiogram monitoring [ Time Frame: during the operation period(five minutes after beginning of surgery ] [ Designated as safety issue: Yes ]
  • heart rate will be assessed by echocardiogram monitoring [ Time Frame: postoperatively before discharge the patient from the recovery room ] [ Designated as safety issue: Yes ]
  • satisfaction of surgeon according to three degree scale as very bad, moderate, good will be assessed [ Time Frame: one minute after retrobulbar block placement ] [ Designated as safety issue: Yes ]
  • satisfaction of surgeon according to three degree scale as very bad, moderate, good will be assessed [ Time Frame: at the end of surgery ] [ Designated as safety issue: Yes ]

Enrollment: 90
Study Start Date: September 2010
Study Completion Date: January 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: melatonin

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

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).

Active Comparator: gabapentin

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

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 Comparator: placebo

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

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).


  Eligibility

Ages Eligible for Study:   35 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01200641

Locations
Iran, Islamic Republic of
Qazvin university of medical science
Qazvin, Iran, Islamic Republic of, 34197/59811
Sponsors and Collaborators
Qazvin University Of Medical Sciences
  More Information

No publications provided

Responsible Party: marzieh beigom khezri, Qazvin University Of Medical Sciences
ClinicalTrials.gov Identifier: NCT01200641     History of Changes
Other Study ID Numbers: ACTRN12610000727044
Study First Received: September 10, 2010
Last Updated: October 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Qazvin University Of Medical Sciences:
melatonin
gabapentin
anxiety
pain
retrobulbar block

Additional relevant MeSH terms:
Anxiety Disorders
Cataract
Mental Disorders
Lens Diseases
Eye Diseases
Melatonin
Gabapentin
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on July 23, 2014