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NCT Number: NCT01200641

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

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.

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Key information

Age range

35 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Qazvin university of medical science

Qazvin, Qazvin Province, 34197/59811, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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).

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).

Primary outcomes

  1. 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

  2. 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)

  3. 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

  4. 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)

  5. 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

  6. 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

Secondary outcomes

  1. mean arterial blood pressure will be assessed by noninvasive automatic blood pressure measurement

    Time frame: before premedication

  2. 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

  3. mean arterial blood pressure will be assessed by noninvasive automatic blood pressure measurement

    Time frame: one minute after retrobulbar block placement

  4. 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

  5. mean arterial blood pressure will be assessed by noninvasive automatic blood pressure measurement

    Time frame: postoperatively before discharge the patient from the recovery room

  6. heart rate will be assessed by echocardiogram monitoring

    Time frame: before premedication

  7. heart rate will be assessed by echocardiogram monitoring

    Time frame: ninety minutes after premedication, on arrival in the operating room

  8. heart rate will be assessed by echocardiogram monitoring

    Time frame: one minute after retrobulbar block placement

  9. heart rate will be assessed by echocardiogram monitoring

    Time frame: during the operation period(five minutes after beginning of surgery

  10. heart rate will be assessed by echocardiogram monitoring

    Time frame: postoperatively before discharge the patient from the recovery room

  11. satisfaction of surgeon according to three degree scale as very bad, moderate, good will be assessed

    Time frame: one minute after retrobulbar block placement

  12. satisfaction of surgeon according to three degree scale as very bad, moderate, good will be assessed

    Time frame: at the end of surgery

Sponsors and collaborators

Lead sponsor

Qazvin University Of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Sep 13, 2010
Registry last updated
Oct 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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