The Role of Preoperative Melatonin in Reducing the Inhaled Isoflurane Requirements in Open Nephrectomy
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Melatonin is a hormone that the pineal gland in the brain produces. Melatonin fulfills many
      functions in the body but it is mostly known for maintaining a circadian rhythm that is
      governed by the central circadian pacemaker (biological clock) in the suprachiasmatic nuclei
      in the hypothalamus. Melatonin works by attaching to receptors or nerve endings in the
      suprachiasmatic nucleus (SCN) in the hypothalamus. It binds to melatonin receptor 1 and
      melatonin receptor 2, commonly referred to as MT1 and MT2. People can take it as a natural or
      synthetic supplement to promote restful sleep. Melatonin showed promise for preventing shifts
      in sleep and wake times in people with jetlag and improving sleep in people with insomnia. It
      can also be used for headaches, cancer, and Alzheimer's disease.

      Melatonin can be used as an analgesic, sedative, and hypnotic drug that can distinguish it as
      an attractive alternative premedicant
    

Detailed description: 
      A study that was done before in J Anaesth by Borazan H et al revealed that postoperative pain
      score in patients undergoing radical prostatectomy who received melatonin one hour before
      surgery as a premedication was significantly lower than the control group with a significant
      P-value( less than 0.05).

      The entropy is indicated for adult and pediatric patients older than 2 years intraoperatively
      for monitoring the electric state of the brain. In adult patients, state entropy and response
      entropy can be used as an aid in monitoring the effects of certain anaesthetic agents which
      will help the user to titrate the anaesthetic agent according to the individual needs of each
      patient.

      Furthermore, the use of entropy parameters may be associated with a reduction of anaesthetic
      use and faster emergence of anaesthesia. The entropy measurement is to be used as an adjunct
      to other physiological parameters.

      To the best of investigators knowledge, there is no study that examined the effect of
      melatonin on inhaled isoflurane requirements intraoperatively. So, in this study, the effect
      of melatonin will be assessed on intraoperative inhaled isoflurane requirements in patients
      undergoing open nephrectomy under general anaesthesia by using entropy
    

Intervention name(s): Melatonin 5 mg; Sugar Coated Tablets
Intervention type(s): Drug; Drug
Intervention description(s): study the effect of preoperative oral melatonin 5mg on isoflurane consumption and postoperative pain; the control group patients will receive placebo tablets one hour before induction of anesthesia
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research