Patients Undergoing Lumbar FixationNCT05632159
Effect of Intraoperative Magnesium Sulphate on the Occurrence of Postoperative Delirium
A study testing Mg sulphate and conventional anaesthesia in people with Patients Undergoing Lumbar Fixation, run by Beni-Suef University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Patients Undergoing Lumbar Fixation
- What is being tested?
- Mg sulphate and conventional anaesthesia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2022to 15 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-II patients undergoing lumbar fixation.
- Male and female patients with age range between 20-70 years.
Who cannot join
- 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 .
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Beni-Suef University
Banī Suwayf, 62511
Mona Hussein, MD, 01005131318 ext. +2, mona.neuro@yahoo.com
About this study
Official title: Effect of Intraoperative Magnesium Sulphate on the Occurrence of Postoperative Delirium and Insomnia in Patients Undergoing Lumbar Fixation
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)
Read more
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.
Read the detailed description
Study design and Participants:
This prospective randomized controlled trial will be carried out on 80 patients indicated for lumbar fixation. The selected patients will be randomly assigned to one of the following two groups; the first group will receive conventional general anaesthesia only (40 participants) (conventional anaesthesia group), and the second group will receive conventional general anaesthesia with extra administration of intraoperative magnesium sulphate (40 participants) (Mg sulphate group). Randomization will be carried out using a closed opaque envelope technique. The patients will be recruited from the Neurosurgery, Beni-Suef University Hospital, in the period from November, 2021 to May 2022.
Inclusion criteria:
- ASA I-II patients undergoing lumbar fixation.
- Male and female patients with age range between 20-70 years.
Exclusion criteria:
- 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.
The included patients will be subjected to the following
- History taking regarding: demographics, BMI, and co-morbidities
- Assessment of depression using Beck Depression inventory (BDI) scale (15) . It will be done for all included patients one day before surgery. BDI is one of the most widely used instruments for measuring the severity of depression. It is consisted of twenty-one questions about how the subject has been feeling in the last week. Each question has a set of at least four possible answer choices, ranging in intensity from 0 to 3. A score 0-9 indicates minimal depression, a score 10-18 indicates mild depression, a score 19- 29 indicates moderate depression and a score 30-63: indicates severe depression.
- Assessment of fatigue using a fatigue questionnaire. It will be done for all included patients one day before surgery. It is a14-item fatigue scale that assess physical and mental fatigue. Items 1-7 represent physical while items 8-11represent mental fatigue. Each item was scored using a bimodal response system; better than usual or no more than usual = zero, worse than usual or much worse than usual = one. The total score is the sum all items. Scores for physical and mental fatigue are the sum of the representative items for each section. (16) .
- Assessment of insomnia using Insomnia severity index (ISI). It will be done for all included patients one day before and two weeks after surgery. ISI is a 7-item instrument measuring the individual's perception of insomnia symptoms over the previous two weeks. The evaluated dimensions are (severity of sleep onset, sleep maintenance, and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28). (17)
- Assessment of postoperative delirium using Memorial delirium assessment scale (MDAS). It will be done for all included patients between 24 hours and 48 hours after surgery. MDAS is structured as a 10-item, 4-point clinician-rated scale (possible range 0-30) designed to quantify the severity of delirium in medically ill patients. This instrument measures relative impairment in domains itemized as follows: 1, awareness; 2, orientation; 3, short-term memory; 4, digit span; 5, attention capacity; 6, organizational thinking; 7, perceptual disturbance; 8, delusions; 9, psychomotor activity; and 10, sleep-wake cycle. Items are rated on a 4point scale from 0 (none) to 3 (severe) depending on the level of impairment, rendering a maximum possible score of 30. A score of 13 has been recommended as a cut-off for establishing the diagnosis of delirium with a sensitivity of 70.59% and a specificity of 93.75% (18) .
- Assessment of pain using Visual Analogue Scale (VAS). It will be done for all included patients at the night of the first day after 12 hours of the surgery. It is a continuous scale for describing pain severity or intensity. It consists of a horizontal line usually 10 centimeters in length. The ends of the line are defined as the extremes of pain; such as 'no pain at all' and 'worst imaginable pain'. The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain (19) .
- Neurophysiological assessment. Electroencephalography (EEG) and Quantitative electroencephalography (QEEG) will be done for all included patients before, and between 24 hours and 48 hours after surgery. EEG and QEEG will be carried out in the Neuro Diagnostic \& Research Center (NDRC), Beni-Suef University Hospital, using Nihon Kohden EEG Japan machine combined with Neuroguide QEEG software. EEG recording will be carried out for 20 minutes in a quiet room while the subject is relaxed with their eyes closed for 5 minutes and opened for 5 minutes to insure a high arousal level. The EEG scalp electrodes will be applied according to the international 10-20 system using an ear lobe electrode as a reference. The absolute power of 5 electrodes (CZ, T3, T4, T5, T6,) will be studied in the following frequency bands: delta (0.5-3Hz), theta (4-7 Hz) and also the absolute power of (O1, O2) will be studied in delta theta and alpha (8-12 Hz) bands.
- Anaesthesia technique
- A routine preoperative check-up will be performed for all selected patients including routine hematological and biochemical testing, in addition to electrocardiograms .
- On arrival to the operating theatre, 18 G intravenous cannula will be inserted and IV crystalloid fluids will be infused, the monitor will be attached to the patients to take preoperative readings of HR , NIBP , SpO2.
- The patients will be randomly divided to one of two groups:
Group 1:
- 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. Laryngoscopy and endotracheal intubation will be performed using oral cuffed tube lubricated with lidocaine jelly 2 %.
- Maintainance of anesthesia will be done using sevoflurane 1.5-2 %, and Mixture of O2 and Air (70:30).
Group 2:
- 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. Laryngoscopy and endotracheal intubation will be performed using oral cuffed tube lubricated with lidocaine jelly 2 %. With extra administration of intraoperative Magnesium sulphate 30 mg /kg as loading dose over 10 min then 10 mg /kg/ has maintenance dose (20).
- Maintenance of anesthesia will be done using sevoflorane1.5-2% and mixture of O2 and Air (70: 30) .
Ventilation in both groups will be controlled artificially to maintain an endtidal partial pressure of carbon dioxide of 35-45 mmHg.
At the end of surgery, neuromuscular blockade will be reversed with IV neostigmine 0.04mg/kg and atropine 0.02 mg/kg, the trachea will be extubated when the patient respond to commands, all patients will be transferred to PACU, where they receive oxygen via face mask 3-4 L/min and will be monitored.
The following parameters will be evaluated and recorded by senior anesthesiologist unaware of the study protocol:
- Depth of anesthesia
- Duration of anesthesia
- Hemodynamics of the patients including BP and HR, SPO2, and End tidal CO2 will be continuously monitored and recorded every 15 minutes.
- Conditions
- Patients Undergoing Lumbar Fixation
- Being tested
- Mg sulphate, conventional anaesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mg sulphateDrug
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
conventional anaesthesiaDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: Mg sulphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia
Assessment of insomnia using Insomnia severity index
Measured: 2 Weeks
Postoperative delirium using Memorial delirium assessment scale (MDAS).
Assessment of postoperative delirium using Memorial delirium assessment scale (MDAS)
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start1 Nov 2022
- Primary completion1 Feb 2023 (estimated)
- Study completion15 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Undergoing Lumbar FixationStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Evaluating the effect of intraoperative administration of Magnesium sulphate on the occurrence of post-operative delirium and insomnia in those patients.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Hussein, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05632159
- Sponsor's protocol ID
- FMBSUREC/090122022/Abd-Elsadek
- Status last verified
- Nov 2022
- First submitted
- 19 Nov 2022
- Last updated
- 30 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intraoperative Magnesium Sulphate on the Occurrence of Postoperative Delirium and Insomnia in Patients Undergoing Lumbar Fixation
- ClinicalTrials.gov ID
- NCT05632159
- Acronym / sponsor ID
- FMBSUREC/090122022/Abd-Elsadek
- Conditions
- Patients Undergoing Lumbar Fixation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- 15 Mar 2023 (estimated)
- First posted
- 30 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study design and Participants:
This prospective randomized controlled trial will be carried out on 80 patients indicated for lumbar fixation. The selected patients will be randomly assigned to one of the following two groups; the first group will receive conventional general anaesthesia only (40 participants) (conventional anaesthesia group), and the second group will receive conventional general anaesthesia with extra administration of intraoperative magnesium sulphate (40 participants) (Mg sulphate group). Randomization will be carried out using a closed opaque envelope technique. The patients will be recruited from the Neurosurgery, Beni-Suef University Hospital, in the period from November, 2021 to May 2022.
Inclusion criteria:
- ASA I-II patients undergoing lumbar fixation.
- Male and female patients with age range between 20-70 years.
Exclusion criteria:
- 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.
The included patients will be subjected to the following
- History taking regarding: demographics, BMI, and co-morbidities
- Assessment of depression using Beck Depression inventory (BDI) scale (15) . It will be done for all included patients one day before surgery. BDI is one of the most widely used instruments for measuring the severity of depression. It is consisted of twenty-one questions about how the subject has been feeling in the last week. Each question has a set of at least four possible answer choices, ranging in intensity from 0 to 3. A score 0-9 indicates minimal depression, a score 10-18 indicates mild depression, a score 19- 29 indicates moderate depression and a score 30-63: indicates severe depression.
- Assessment of fatigue using a fatigue questionnaire. It will be done for all included patients one day before surgery. It is a14-item fatigue scale that assess physical and mental fatigue. Items 1-7 represent physical while items 8-11represent mental fatigue. Each item was scored using a bimodal response system; better than usual or no more than usual = zero, worse than usual or much worse than usual = one. The total score is the sum all items. Scores for physical and mental fatigue are the sum of the representative items for each section. (16) .
- Assessment of insomnia using Insomnia severity index (ISI). It will be done for all included patients one day before and two weeks after surgery. ISI is a 7-item instrument measuring the individual's perception of insomnia symptoms over the previous two weeks. The evaluated dimensions are (severity of sleep onset, sleep maintenance, and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28). (17)
- Assessment of postoperative delirium using Memorial delirium assessment scale (MDAS). It will be done for all included patients between 24 hours and 48 hours after surgery. MDAS is structured as a 10-item, 4-point clinician-rated scale (possible range 0-30) designed to quantify the severity of delirium in medically ill patients. This instrument measures relative impairment in domains itemized as follows: 1, awareness; 2, orientation; 3, short-term memory; 4, digit span; 5, attention capacity; 6, organizational thinking; 7, perceptual disturbance; 8, delusions; 9, psychomotor activity; and 10, sleep-wake cycle. Items are rated on a 4point scale from 0 (none) to 3 (severe) depending on the level of impairment, rendering a maximum possible score of 30. A score of 13 has been recommended as a cut-off for establishing the diagnosis of delirium with a sensitivity of 70.59% and a specificity of 93.75% (18) .
- Assessment of pain using Visual Analogue Scale (VAS). It will be done for all included patients at the night of the first day after 12 hours of the surgery. It is a continuous scale for describing pain severity or intensity. It consists of a horizontal line usually 10 centimeters in length. The ends of the line are defined as the extremes of pain; such as 'no pain at all' and 'worst imaginable pain'. The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain (19) .
- Neurophysiological assessment. Electroencephalography (EEG) and Quantitative electroencephalography (QEEG) will be done for all included patients before, and between 24 hours and 48 hours after surgery. EEG and QEEG will be carried out in the Neuro Diagnostic \& Research Center (NDRC), Beni-Suef University Hospital, using Nihon Kohden EEG Japan machine combined with Neuroguide QEEG software. EEG recording will be carried out for 20 minutes in a quiet room while the subject is relaxed with their eyes closed for 5 minutes and opened for 5 minutes to insure a high arousal level. The EEG scalp electrodes will be applied according to the international 10-20 system using an ear lobe electrode as a reference. The absolute power of 5 electrodes (CZ, T3, T4, T5, T6,) will be studied in the following frequency bands: delta (0.5-3Hz), theta (4-7 Hz) and also the absolute power of (O1, O2) will be studied in delta theta and alpha (8-12 Hz) bands.
- Anaesthesia technique
- A routine preoperative check-up will be performed for all selected patients including routine hematological and biochemical testing, in addition to electrocardiograms .
- On arrival to the operating theatre, 18 G intravenous cannula will be inserted and IV crystalloid fluids will be infused, the monitor will be attached to the patients to take preoperative readings of HR , NIBP , SpO2.
- The patients will be randomly divided to one of two groups:
Group 1:
- 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. Laryngoscopy and endotracheal intubation will be performed using oral cuffed tube lubricated with lidocaine jelly 2 %.
- Maintainance of anesthesia will be done using sevoflurane 1.5-2 %, and Mixture of O2 and Air (70:30).
Group 2:
- 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. Laryngoscopy and endotracheal intubation will be performed using oral cuffed tube lubricated with lidocaine jelly 2 %. With extra administration of intraoperative Magnesium sulphate 30 mg /kg as loading dose over 10 min then 10 mg /kg/ has maintenance dose (20).
- Maintenance of anesthesia will be done using sevoflorane1.5-2% and mixture of O2 and Air (70: 30) .
Ventilation in both groups will be controlled artificially to maintain an endtidal partial pressure of carbon dioxide of 35-45 mmHg.
At the end of surgery, neuromuscular blockade will be reversed with IV neostigmine 0.04mg/kg and atropine 0.02 mg/kg, the trachea will be extubated when the patient respond to commands, all patients will be transferred to PACU, where they receive oxygen via face mask 3-4 L/min and will be monitored.
The following parameters will be evaluated and recorded by senior anesthesiologist unaware of the study protocol:
- Depth of anesthesia
- Duration of anesthesia
- Hemodynamics of the patients including BP and HR, SPO2, and End tidal CO2 will be continuously monitored and recorded every 15 minutes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Evaluating the effect of intraoperative administration of Magnesium sulphate on the occurrence of post-operative delirium and insomnia in those patients.
| Arm | Type | Receives |
|---|---|---|
| conventional anaesthesia group | Placebo comparator | Drug: conventional anaesthesiaInduction 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. |
| Mg sulphate group | Active comparator | Drug: Mg sulphateInduction 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 |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA I-II patients undergoing lumbar fixation.
- Male and female patients with age range between 20-70 years.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mg sulphateInduction 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 group |
| conventional anaesthesiaInduction 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 group |
Primary outcome
Insomnia
Time frame: 2 Weeks
Assessment of insomnia using Insomnia severity index
Postoperative delirium using Memorial delirium assessment scale (MDAS).
Time frame: 2 days
Assessment of postoperative delirium using Memorial delirium assessment scale (MDAS)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mg sulphate and conventional anaesthesia in people with Patients Undergoing Lumbar Fixation, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia (time frame: 2 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2022.