The Role of Preoperative Melatonin in Reducing the Inhaled Isoflurane Requirements in Open Nephrectomy

Postoperative Pain Clinical Trial

Official title:

Effect of Preoperative Melatonin in Inhaled Anesthetic Consumption

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04959825
• Other study ID #: MD-249-2020
• Status: Completed
• Phase: Early Phase 1
• Start date: July 15, 2021
• Est. completion date: May 15, 2022

Study information

• Verified date: July 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 15, 2022
• Est. primary completion date: April 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients undergoing nephrectomy under general anesthesia aged from 20 to 60 years.

• ASA 1 or 2.

• BMI 25 to 30

Exclusion Criteria:

• Patients with uncontrolled hypertension.

• Patients presenting with (IHD, significant arrhythmias, heart failure).

• Allergy to melatonin.

• History of epileptic seizures, psychoactive medications, neurological disorders or trauma.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Melatonin 5 mg
study the effect of preoperative oral melatonin 5mg on isoflurane consumption and postoperative pain
• Sugar Coated Tablets
the control group patients will receive placebo tablets one hour before induction of anesthesia

Locations

Country	Name	City	State
Egypt	Amany Hassan Saleh	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inhaled isoflurane requirement (volume%) to maintain entropy readings 40-60	Inhaled Isoflurane requirement (volume %) will be titrated to maintain state entropy (SE) and response entropy (RE) readings 40-60 measured using GE carestation 650-crescent pulse anaesthesia machine(6).	2 hours
Secondary	Total morphine consumption over 24 hours postoperative		24 hours
Secondary	Total intraoperative fentanyl consumption	The sum of fentanyl top up doses will be recorded	2 hours