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Premedication With Melatonin and Alprazolam Combination Versus Alprazolam or Melatonin Alone

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Krishna Pokharel, B.P. Koirala Institute of Health Sciences
ClinicalTrials.gov Identifier:
NCT01486615
First received: November 10, 2011
Last updated: September 6, 2012
Last verified: September 2012
  Purpose

Background: Benzodiazepine, a common premedicant, suppresses endogenous melatonin levels and thus paradoxically increases episodes of arousal during sleep and thus causes restlessness and hangs over effects. Adding melatonin to it may decrease nocturnal arousal and promote the perception of sound sleep in the perioperative period.

Methods: Eighty patients (ASA 1&2) with anxiety VAS ≥ 2 posted for general anaesthesia will be randomly assigned to receive 0.5 mg alprazolam (Group A), 3 mg melatonin, a combination of 0.5 mg alprazolam and 3 mg melatonin (Group AM), or a similar looking placebo (Group P), approximately 90 minutes before surgery.


Condition Intervention Phase
Anxiety
Drug: meloset (melatonin)
Drug: stresnil ( melatonin and alprazolam)
Drug: (alprax) alprazolam
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Premedication With Melatonin and Alprazolam Combination Versus Alprazolam or Melatonin Alone: a Randomized, Double Blind Placebo Controlled Study

Resource links provided by NLM:


Further study details as provided by B.P. Koirala Institute of Health Sciences:

Primary Outcome Measures:
  • Change in VAS Anxiety Score Relative to Baseline After Premedication [ Time Frame: Change from baseline in VAS anxiety score at 15 minutes after premedication ] [ Designated as safety issue: No ]
    VAS (Visual Analogue Score) Anxiety Scale is a 10 cm long scale with two sides, the patient side (front) and the clinicians side (back). The extremes of the front are colored as white and black with a gradual darkening of color from white to black. The back is marked in centimeter from 0 to 10 and 0 correlates with white color (no anxiety at all) and 10 correlates to black color (anxiety as bad as ever can be) on the front. As anxiety is worsened, the color is darker and score is more. The maximum score is 10 and minimum 0. The patient is asked to point on the scale according to his anxiety level. The anxiety score is the correlating number on the clinicians side. The more the reduction in anxiety from baseline, the better the outcome.

  • Change in VAS Anxiety Score Relative to Baseline at 30 Minutes After Premedication [ Time Frame: Changes from baseline in VAS anxiety score at 30 minutes after premedication ] [ Designated as safety issue: No ]
    VAS (Visual Analogue Score) Anxiety Scale is a 10 cm long scale with two sides, the patient side (front) and the clinicians side (back). The extremes of the front are colored as white and black with a gradual darkening of color from white to black. The back is marked in centimeter from 0 to 10 and 0 correlates with white color (no anxiety at all) and 10 correlates to black color (anxiety as bad as ever can be) on the front. As anxiety is worsened, the color is darker and score is more. The maximum score is 10 and minimum 0. The patient is asked to point on the scale according to his anxiety level. The anxiety score is the correlating number on the clinicians side. The more the reduction in anxiety from baseline, the better the outcome.

  • Change in VAS Anxiety Score Relative to Baseline at One Hour After Premedication [ Time Frame: Changes from baseline in VAS anxiety score at one hour after premedication ] [ Designated as safety issue: No ]
    VAS (Visual Analogue Score) Anxiety Scale is a 10 cm long scale with two sides, the patient side (front) and the clinicians side (back). The extremes of the front are colored as white and black with a gradual darkening of color from white to black. The back is marked in centimeter from 0 to 10 and 0 correlates with white color (no anxiety at all) and 10 correlates to black color (anxiety as bad as ever can be) on the front. As anxiety is worsened, the color is darker and score is more. The maximum score is 10 and minimum 0. The patient is asked to point on the scale according to his anxiety level. The anxiety score is the correlating number on the clinicians side. The more the reduction in anxiety from baseline, the better the outcome.


Secondary Outcome Measures:
  • Sedation Score at One Hour After Premedication [ Time Frame: Sedation score at 1 hour after the premedication ] [ Designated as safety issue: No ]
    Sedation level was assessed with a 5 point scale (0=alert, 1=arouses to voice, 2=arouses with gentle tactile stimulation, 3=arouses with vigorous tactile stimulation, 4=lack of responsiveness). Minimum score is 0 and Maximum is 4. The lesser the score, the better the outcome.

  • Orientation Score [ Time Frame: Orientation score at one hour after premedication ] [ Designated as safety issue: No ]
    Orientation was assessed with a 3 point scale (0=none, 1=orientation in either time or place, 2=orientation in both). Minimum score is 0 and maximum is 2. The lesser the score, the lesser the effect on patients cognition and the better the outcome.

  • Number of Patients With Intact Memory [ Time Frame: 24 hour after surgery ] [ Designated as safety issue: No ]
    Number of patients who recalled or recognized the picture number five shown one hour after premedication. The more the number of patients with intact memory, the better the outcome.

  • Amount of Propofol Consumption [ Time Frame: 1 - 2 hour after premedication ] [ Designated as safety issue: No ]
    Dose of propofol needed for loss of response to verbal command was noted at the time of induction of general anesthesia. The lesser the propofol needed for the loss of response to verbal command, the better the outcome.

  • Number of Patients With Loss of Memory for Being Transferred to Operating Room. [ Time Frame: 24 hour after surgery ] [ Designated as safety issue: No ]
    Patients were asked whether they recalled the event of being transferred to the operating room before anaesthesia. The lesser the number of patients with amnesia, the better the outcome.


Enrollment: 80
Study Start Date: October 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Melatonin
Premedication with 3 mg melatonin (Meloset) tablet orally 1-2 hour prior to anesthesia
Drug: meloset (melatonin)
3 mg melatonin tablet 1-2 hour prior surgery
Placebo Comparator: melatonin and alprazolam premedication
Premedication with 3 mg melatonin and 0.5 mg alprazolam (Stresnil) tablet orally 1-2 hrs prior to anesthesia
Drug: stresnil ( melatonin and alprazolam)
3 mg melatonin and 0.5 mg alprazolam 1-2 hr before anesthesia
Placebo Comparator: alprazolam premedication
Premedication with 0.5 mg alprazolam (Alprax) tablet orally 1-2 hr prior to anesthesia
Drug: (alprax) alprazolam
0.5 mg alprazolam
Active Comparator: placebo premedication
Premedication with a similar looking placebo tablet orally 1-2 hr prior to anesthesia
Drug: placebo
similar looking placebo tablet

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • (ASA 1&2),
  • aging 18 to 65 years
  • having anxiety VAS score of more than 2
  • posted for general anaesthesia with estimated duration of < 3 hours.

Exclusion Criteria:

  • patients taking analgesics, sedatives, antiepileptics or antidepressants,
  • suffering from obesity (BMI ≥ 28) or neuropsychiatric disease,
  • having allergy to the study drugs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01486615

Locations
Nepal
B. P. Koirala Institute of Health Sciences
Dharan, Koshi, Nepal, 56700
Dr Krishna Pokharel
Dharan, Koshi, Nepal, 56700
Sponsors and Collaborators
B.P. Koirala Institute of Health Sciences
Investigators
Principal Investigator: Krishna Pokharel, MD B.P. Koirala Institute of Health Sciences
Study Director: Balkrishna Bhattarai, MD B.P. Koirala Institute of Health Sciences
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Krishna Pokharel, Associate Professor, B.P. Koirala Institute of Health Sciences
ClinicalTrials.gov Identifier: NCT01486615     History of Changes
Other Study ID Numbers: 2/18 (Acd. 796/067/068)
Study First Received: November 10, 2011
Results First Received: May 20, 2012
Last Updated: September 6, 2012
Health Authority: Nepal: Health Research Council

Keywords provided by B.P. Koirala Institute of Health Sciences:
premedication
premedicants
preoperative anxiety
melatonin
alprazolam

Additional relevant MeSH terms:
Alprazolam
Melatonin
Anti-Anxiety Agents
Antioxidants
Central Nervous System Agents
Central Nervous System Depressants
GABA Agents
GABA Modulators
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 19, 2014