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

• Sponsor: Cairo University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04959825
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Actual Duration (Months): 10
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Drug: Melatonin 5 mg; Drug: Sugar Coated Tablets	Early Phase 1

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: randomized controlled trialrandomized controlled trial
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Patients will be allocated to the study groups using a computer-generated random list, and the group assignments will be sealed in sequentially numbered opaque envelopes that will be opened before induction of anesthesia. The data collector will be blinded to the group assignment and to the monitoring anesthetist, and the person who will give the drug will not bethe data collector.
• Primary Purpose: Health Services Research
• Official Title: Effect of Preoperative Melatonin in Inhaled Anesthetic Consumption
• Actual Study Start Date: Jul 15, 2021
• Actual Primary Completion Date: Apr 10, 2022
• Actual Study Completion Date: May 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: melatonin group Melatonin group (group M )will receive melatonin as a premedication 1 hour before surgery in a dose of 5 mg	Drug: Melatonin 5 mg; study the effect of preoperative oral melatonin 5mg on isoflurane consumption and postoperative pain
Placebo Comparator: control group 15 patients will be enrolled for open nephrectomy will receive sugar-coated tablets. Control group(group C)	Drug: Sugar Coated Tablets; the control group patients will receive placebo tablets one hour before induction of anesthesia

Outcome Measures

Primary Outcome Measures

1. Inhaled isoflurane requirement (volume%) to maintain entropy readings 40-60 [2 hours]

   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).

Secondary Outcome Measures

1. Total morphine consumption over 24 hours postoperative [24 hours]

2. Total intraoperative fentanyl consumption [2 hours]

   The sum of fentanyl top up doses will be recorded

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Amany Hassan Saleh	Giza		Egypt	02

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Amany Hassan Saleh, Associate professor of anesthesia, surgical intensive care and pain management, Cairo University, Cairo University
• ClinicalTrials.gov Identifier: NCT04959825
• Other Study ID Numbers: MD-249-2020
• First Posted: Jul 13, 2021
• Last Update Posted: Jul 20, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pain, Postoperative; Melatonin

Study Results

No Results Posted as of Jul 20, 2022