Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06512155
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-24
Brief Title:
Improving Perioperative Sleep Disorders
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Pregabalin on Perioperative Sleep Quality in Orthopedic Surgery Patients a Prospective Randomized Controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In todays day of increasing surgical volume perioperative sleep disorders are an issue that cannot be ignored They are an important component of perioperative brain protection Physiologically and psychologically sleep disorders cause serious damage to patients The application of pregabalin aims to improve the sleep quality of hand surgery patients and its anti anxiety effect can also alleviate preoperative anxiety At the same time its analgesic mechanism is different from that of opioid drugs which is also conducive to reducing the use of opioid drugs Therefore we propose the following hypothesis for orthopedic patients with high incidence of postoperative pain and sleep disorders the use of pregabalin will improve the perioperative sleep quality of such patientsTo test the above hypothesis our research group plans to conduct this prospective randomized positive control study
Detailed Description:
Perioperative sleep disorders mainly refer to the syndrome in which patients undergoing surgery experience disrupted sleep wake rhythms before andor after surgery leading to abnormal sleep quality or behavior during sleep Clinical manifestations include fragmented sleep easy awakening at night difficulty falling asleep insufficient sleep time early bedtime or disrupted sleep rhythm at least one day before or after surgery The latest meta-analysis study indicates that the incidence of preoperative sleep disorders in surgical patients is as high as 60 After surgery about 60-70 of patients will have postoperative sleep disorder PSD and even 23 of patients will have sleep disorder until the fourth day after surgery Among various surgeries orthopedic surgery has a high incidence of PSD due to its long operation time and wide surgical range In the study by Duan G and colleagues the PSD incidence rate of spinal orthopedic surgery in orthopedics was 354 and the PSD incidence rate of limb surgery was 27
Sleep disorders may lead to a range of complications including cognitive impairment delayed postoperative recovery acute pain and cardiovascular accidents In the hospital environment factors that lead to poor sleep include pain anxiety noise interference from hospital staff continuous ambient lighting and uncomfortable beds After completing the surgery factors such as the size of the surgery the use of opioid drugs inflammatory mediators the release of various hormones and pain contribute to a high incidence of sleep disorders with pain being the most common cause and there is an interactive relationship between postoperative sleep disorders and pain It is worth noting that patients with poor preoperative sleep quality have a higher probability of developing sleep disorders after surgery Therefore it is necessary to comprehensively consider these factors and take corresponding preventive measures to reduce the incidence of perioperative sleep disorders
According to the sleep care guidelines for postoperative patients entering the ICU maintaining a quiet and dim environment and reducing interruptions in nighttime care activities are recommended to improve sleep quality and efficiency A meta-analysis shows that the use of earplugs and eye masks also helps promote sleep in ICU patients However it is evident that this method is not suitable for patients who are admitted to regular multi person wards after surgery Although in a meta-analysis there was insufficient evidence to suggest that drug therapy can improve the quality or quantity of sleep in patients with poor postoperative sleep Even compared to placebo or no treatment there is no established drug category or specific drug that is superior to placebo or no treatment 6 However drug therapy is still widely used for patients with perioperative sleep disorders due to its convenience strong feasibility and high patient acceptance
In current clinical practice the main drugs used to address perioperative sleep disorders are sleeping pills and painkillers Specifically sleeping pills are mainly divided into first generation second generation and third generation sedative hypnotic drugs These drugs mainly exert extensive inhibition on the central nervous system causing it to transition from an excited state to an inhibited state However their effect on improving sleep structure is not satisfactory especially the second-generation drugs - benzodiazepines which can change the usual sleep pattern prolong shallow sleep shorten the duration of REM sleep and delay the appearance of the first REM sleep This change which is similar to the postoperative sleep structure is more detrimental to the improvement of patients sleep therefore the effect is not satisfactory As for painkillers opioids are the most commonly used class in clinical practice Even though they have strong analgesic effects they have been found to dose dependently inhibit REM and SWS sleep in normal volunteers and animal experiments In addition in Cronin AJ et als study postoperative patients suffered from severe sleep disorders even when avoiding opioid use and pain was well controlled Therefore the improvement of sleep in perioperative patients cannot be limited to the use of the above two drugs
Pregabalin is a gabapentin class drug that inhibits the influx of calcium ions into the presynaptic membrane of neurons and reduces the release of excitatory neurotransmitters including glutamate aspartic acid substance P calcitonin gene-related peptide norepinephrine serotonin dopamine etc by binding to the α 2 δ pressure group containing voltage-gated calcium channels Its analgesic anti anxiety and anticonvulsant effects are widely used in various clinical diseases Pregabalin has been approved for the treatment of neuropathic pain and partial seizures in the United States and Europe It can also be used for fibromyalgia in the United States and for the treatment of generalized anxiety disorder in Europe While treating patients with this type of chronic disease its effect on improving sleep has been discovered Studies have found that pregabalin exhibits significant sleep improvement effects from the initial stage of medication and its therapeutic efficacy is maintained throughout the entire treatment phase Similar sleep improvement effects to alprazolam have also been found in normal healthy individuals The mechanism by which pregabalin improves sleep is still unclear and it is speculated to be related to its ability to reduce excitatory neurotransmitters Currently there is no relevant research on the impact of pregabalin on sleep quality in perioperative patients
Sleep disorders may lead to a range of complications including cognitive impairment delayed postoperative recovery acute pain and cardiovascular accidents In the hospital environment factors that lead to poor sleep include pain anxiety noise interference from hospital staff continuous ambient lighting and uncomfortable beds After completing the surgery factors such as the size of the surgery the use of opioid drugs inflammatory mediators the release of various hormones and pain contribute to a high incidence of sleep disorders with pain being the most common cause and there is an interactive relationship between postoperative sleep disorders and pain It is worth noting that patients with poor preoperative sleep quality have a higher probability of developing sleep disorders after surgery Therefore it is necessary to comprehensively consider these factors and take corresponding preventive measures to reduce the incidence of perioperative sleep disorders
According to the sleep care guidelines for postoperative patients entering the ICU maintaining a quiet and dim environment and reducing interruptions in nighttime care activities are recommended to improve sleep quality and efficiency A meta-analysis shows that the use of earplugs and eye masks also helps promote sleep in ICU patients However it is evident that this method is not suitable for patients who are admitted to regular multi person wards after surgery Although in a meta-analysis there was insufficient evidence to suggest that drug therapy can improve the quality or quantity of sleep in patients with poor postoperative sleep Even compared to placebo or no treatment there is no established drug category or specific drug that is superior to placebo or no treatment 6 However drug therapy is still widely used for patients with perioperative sleep disorders due to its convenience strong feasibility and high patient acceptance
In current clinical practice the main drugs used to address perioperative sleep disorders are sleeping pills and painkillers Specifically sleeping pills are mainly divided into first generation second generation and third generation sedative hypnotic drugs These drugs mainly exert extensive inhibition on the central nervous system causing it to transition from an excited state to an inhibited state However their effect on improving sleep structure is not satisfactory especially the second-generation drugs - benzodiazepines which can change the usual sleep pattern prolong shallow sleep shorten the duration of REM sleep and delay the appearance of the first REM sleep This change which is similar to the postoperative sleep structure is more detrimental to the improvement of patients sleep therefore the effect is not satisfactory As for painkillers opioids are the most commonly used class in clinical practice Even though they have strong analgesic effects they have been found to dose dependently inhibit REM and SWS sleep in normal volunteers and animal experiments In addition in Cronin AJ et als study postoperative patients suffered from severe sleep disorders even when avoiding opioid use and pain was well controlled Therefore the improvement of sleep in perioperative patients cannot be limited to the use of the above two drugs
Pregabalin is a gabapentin class drug that inhibits the influx of calcium ions into the presynaptic membrane of neurons and reduces the release of excitatory neurotransmitters including glutamate aspartic acid substance P calcitonin gene-related peptide norepinephrine serotonin dopamine etc by binding to the α 2 δ pressure group containing voltage-gated calcium channels Its analgesic anti anxiety and anticonvulsant effects are widely used in various clinical diseases Pregabalin has been approved for the treatment of neuropathic pain and partial seizures in the United States and Europe It can also be used for fibromyalgia in the United States and for the treatment of generalized anxiety disorder in Europe While treating patients with this type of chronic disease its effect on improving sleep has been discovered Studies have found that pregabalin exhibits significant sleep improvement effects from the initial stage of medication and its therapeutic efficacy is maintained throughout the entire treatment phase Similar sleep improvement effects to alprazolam have also been found in normal healthy individuals The mechanism by which pregabalin improves sleep is still unclear and it is speculated to be related to its ability to reduce excitatory neurotransmitters Currently there is no relevant research on the impact of pregabalin on sleep quality in perioperative patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None