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

NCT04959825 | Completed Early Phase 1 DMC

• 1 other identifier: MD-249-2020
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Total morphine consumption over 24 hours postoperative

  24 hours

• Total intraoperative fentanyl consumption

  2 hours

Study Arms (2)

melatonin group

ACTIVE COMPARATOR

Melatonin group (group M )will receive melatonin as a premedication 1 hour before surgery in a dose of 5 mg

Drug: Melatonin 5 mg

control group

PLACEBO COMPARATOR

15 patients will be enrolled for open nephrectomy will receive sugar-coated tablets. Control group(group C)

Drug: Sugar Coated Tablets

Interventions

Melatonin 5 mg DRUG

study the effect of preoperative oral melatonin 5mg on isoflurane consumption and postoperative pain

melatonin group

Sugar Coated Tablets DRUG

the control group patients will receive placebo tablets one hour before induction of anesthesia

control group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients undergoing nephrectomy under general anesthesia aged from 20 to 60 years.
• ASA 1 or 2.
• BMI 25 to 30

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Amany Hassan Saleh

Giza, 02, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of anesthesia, surgical intensive care and pain management, Cairo University

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: July 2, 2021
• First Posted: July 13, 2021
• Study Start: July 15, 2021
• Primary Completion: April 10, 2022
• Study Completion: May 15, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)