Effect of Intraoperative Magnesium Sulphate on the Occurrence of Postoperative Delirium

NCT05632159 | Unknown

• 1 other identifier: FMBSUREC/090122022/Abd-Elsadek
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Anaesthesia-related complications and mortality have been significantly reduced in the last years.(1) Nevertheless, anaesthesia-related side effects, such as post-operative delirium and sleep disturbances should not be underestimated. These side effects are economically challenging because they may lead to prolonged hospital stay and change in lifestyle condition. (2) After general anesthesia' sleep disturbances frequently occur. They are featured by insomnia' hyperinsomnia' narcolepsy' and changed sleep structure. (3.4) There are a lot of risk factors associated with post-operative sleep disturbance such as patient age, preoperative comorbidity, severity of surgical trauma, postoperative pain, postoperative complications and presence of pre-operative fatigue and depression. (5) Insomnia is one of the most prevalent health problems during pre-operative period and after post-operative recovery. It can lead to increase incidence of post-operative complications such as delayed recovery , anxiety and delirium (6). Post-operative delirium is also one of the most common complications following anaesthesia with frequency estimates ranging from 10 to 50%. It is defined as delirium occurring 24 to 72 hours after surgery. (7) There are multiple risk factors for developing postoperative delirium including pre-existing dementia, old age, medical co-morbidities, and psycopathological symptoms. The recognition and treatment of Post-operative delirium is critically important because postoperative delirium is associated with poor outcomes including functional decline, dementia, cognitive impairment, increased hospital length of stay , increased mortality ( 11% increasing in the risk of death at 3 months and up to a 17% increased risk of death at 1 year. (8) Animal studies have found that Magnesium can regulate melatonin production which is a hormone that guide body sleep wake cycle (9) . Magnesium is an essential cofactor for many enzymatic reactions' especially those that are involved in energy metabolism and neurotransmitter synthesis. It is a cofactor involved in more than 300 enzyme systems' regulates diverse biochemical reactions in the body (10.11) . Magnesium supplements were used to improve insomnia symptom among older people in a double blinded placebo controlled clinical trial(12). Low dietary Magnesium intake was found to be significantly associated with depression which is a potential risk factor for insomnia(13). Also using Magnesium sulphate as an adjuvant has been associated with significantly less analgesic requirements and reducing postoperative pain which can improve quality of sleep and decrease insomnia symptoms.(14) AIM OF THE STUDY The aim of this work is to identify the potential predictors of postoperative delirium and insomnia in patients undergoing lumbar fixation under general anesthesia, and to evaluate the effect of intraoperative administration of Magnesium sulphate on the occurrence of post-operative delirium and insomnia in those patients.

Conditions

Patients Undergoing Lumbar Fixation

Outcome Measures

Primary Outcomes (2)

• Insomnia

  Assessment of insomnia using Insomnia severity index

  2 Weeks

• Postoperative delirium using Memorial delirium assessment scale (MDAS).

  Assessment of postoperative delirium using Memorial delirium assessment scale (MDAS)

  2 days

Study Arms (2)

conventional anaesthesia group

PLACEBO COMPARATOR

Induction of anesthesia will be done by injecting fentanyl 2 μg/kg, propofol1.5-2.5 mg/kg and atracurium 0.5 mg/kg for muscle relaxation.

Drug: conventional anaesthesia

Mg sulphate group

ACTIVE COMPARATOR

Induction of anesthesia will be done by injecting fentanyl 2 μg/kg, propofol1.5-2.5 mg/kg and atracurium 0.5 mg/kg for muscle relaxation. With extra administration of intraoperative Magnesium sulphate 30 mg /kg as loading dose over 10 min then 10 mg /kg/ has maintenance dose

Drug: Mg sulphate

Interventions

Mg sulphate DRUG

Induction of anesthesia will be done by injecting fentanyl 2 μg/kg, propofol1.5-2.5 mg/kg and atracurium 0.5 mg/kg for muscle relaxation. With extra administration of intraoperative Magnesium sulphate 30 mg /kg as loading dose over 10 min then 10 mg /kg/ has maintenance dose

Mg sulphate group

conventional anaesthesia DRUG

Induction of anesthesia will be done by injecting fentanyl 2 μg/kg, propofol1.5-2.5 mg/kg and atracurium 0.5 mg/kg for muscle relaxation.

conventional anaesthesia group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I-II patients undergoing lumbar fixation.
• Male and female patients with age range between 20-70 years.

You may not qualify if:

• Patients having gross hemodynamic or ventilatory fluctuations during the operation.
• Patients who develop postoperative shock, major bleeding or complication.
• Patients with a history of chronic pain that may interfere with sleep
• Patients with sleep apnea syndrome.
• Patient with a history of neurodegenerative disease, concomitant medical or metabolic illness known to affect sleep (e.g., thyroid, chest or cardiac disorders).
• Patients with a history of psychiatric disorders .
• Patients with a current history of illicit drug use.
• Patients using hypnotic, anxiolytic, or antipsychotic drugs .
• Allergy to any of the drugs that will be used in the study.
• Pregnancy.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni-Suef University

Banī Suwayf, 62511, Egypt

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of Neurology

Model Details: Evaluating the effect of intraoperative administration of Magnesium sulphate on the occurrence of post-operative delirium and insomnia in those patients.

Study Record Dates

• First Submitted: November 19, 2022
• First Posted: November 30, 2022
• Study Start: November 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: March 15, 2023
• Last Updated: November 30, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)