Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06407518
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-05-02
Brief Title:
Preoperative Oral Midazolam to Postoperative Pain Relief in Sleep Disturbance or Anxiety Patients With Colorectal Cancer
Sponsor:
Sixth Affiliated Hospital Sun Yat-sen University
Organization:
Sixth Affiliated Hospital Sun Yat-sen University
Study Overview
Official Title:
Effects of Preoperative Oral Mmidazolam on Postoperative Pain in Sleep Disturbance or Anxiety Patients Undergoing Laparoscopic Colorectal Cancer Resection- A Prospective Randomized Double-blind Placebo-controlled Clinical 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:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POMPPR
Brief Summary:
Previous studies have indicated a high incidence of sleep disturbances and anxiety symptoms in individuals with colorectal cancers prior to undergoing surgery leading to worsened postoperative pain slower recovery and higher risk of chronic pain The enhancement of sleep quality is intricately linked to reducing stress Preoperative drugs that combine hypnosis and anti-anxiety have not been studied in colorectal cancer patients Midazolam oral solution is safe and effective for short-term hypnotic and anti-anxiety effects in clinical preoperative settings In the current randomized controlled clinical trial 280 patients experiencing sleep disturbance or anxiety prior to colorectal cancer surgery will receive midazolam solution to assess its potential efficacy in reducing postoperative pain expediting recovery and decreasing the likelihood of chronic pain Additionally the study aims to explore the potential connections between midazolam administration and reductions in stress and inflammation
Detailed Description:
Preoperative sleep disturbance and anxiety worsen postoperative pain for patients undergoing surgeries Research indicates that a significant proportion of patients ranging from 88 to 791 experience disturbances in sleep or anxiety prior to surgery These preoperative issues have been shown to have lasting and intricate effects on postoperative pain fatigue and depression Therefore it is imperative for clinical doctors to promptly identify preoperative sleep disturbances and anxiety in order to offer appropriate support to patients
Colorectal cancer is the fifth leading cause of death in China with nearly 40 of patients experiencing insomnia before surgery consistent with our previous studies A case-control study demonstrated a protective association between improved sleep quality and relief of postoperative pain in colorectal cancers Furthermore individuals undergoing laparoscopic colorectal surgery showed a higher likelihood of experiencing visceral pain compared to somatic pain Acute visceral pain has the potential to progress into chronic visceral pain resulting in behavioral manifestations such as anxiety fear and depression which may persist and exacerbate into enduring chronic pain ultimately impacting the individuals quality of life Currently studies have shown that disturbed preoperative sleep has become a significant predictor of both acute and chronic postoperative pain Therefore finding effective interventions to promote preoperative sleep is a continuing consideration for clinicians
Pharmacological intervention is the primary approach for preoperative sleep disturbances or anxiety Finding appropriate drug is a challenge that needs to be solved in the clinical practice There is currently a lack of evidence-based medical guidelines regarding pharmacologic interventions for preoperative sleep disturbances and anxiety Research has indicated that zolpidem can enhance sleep quality in patients prior to surgery decrease the need for analgesics during the procedure and alleviate postoperative pain Nevertheless there is a demand for agents that possess both short-term hypnotic and anxiolytic properties whereas zolpidem solely exhibits hypnotic effects Midazolam a short-acting benzodiazepine is often used before anesthesia for its short-term hypnotic and anxiolytic effects Studies have found that midazolam oral solution is safe and effective for short-term use in clinical pre-surgical settings There are no studies on using oral midazolam solution to improve sleep and reduce anxiety in colorectal cancer patients before surgery Our previous research found that a dose of 72mg can effectively induce sleep with minimal side effects in 50 patients before surgery
In summary the present study intends to carry out a prospectiverandomizeddouble-blindplacebo-controlled clinical study to investigate the hypothesis that preoperative oral midazolam solution could reduce acute postoperative pain promote early recovery and reduce the risk of chronic pain in patients with poor sleep or anxiety before colorectal cancer surgery It is postulated that the potential benefits of preoperative oral midazolam solution may be attributed to decreased stress levels and lowered inflammation markers
Colorectal cancer is the fifth leading cause of death in China with nearly 40 of patients experiencing insomnia before surgery consistent with our previous studies A case-control study demonstrated a protective association between improved sleep quality and relief of postoperative pain in colorectal cancers Furthermore individuals undergoing laparoscopic colorectal surgery showed a higher likelihood of experiencing visceral pain compared to somatic pain Acute visceral pain has the potential to progress into chronic visceral pain resulting in behavioral manifestations such as anxiety fear and depression which may persist and exacerbate into enduring chronic pain ultimately impacting the individuals quality of life Currently studies have shown that disturbed preoperative sleep has become a significant predictor of both acute and chronic postoperative pain Therefore finding effective interventions to promote preoperative sleep is a continuing consideration for clinicians
Pharmacological intervention is the primary approach for preoperative sleep disturbances or anxiety Finding appropriate drug is a challenge that needs to be solved in the clinical practice There is currently a lack of evidence-based medical guidelines regarding pharmacologic interventions for preoperative sleep disturbances and anxiety Research has indicated that zolpidem can enhance sleep quality in patients prior to surgery decrease the need for analgesics during the procedure and alleviate postoperative pain Nevertheless there is a demand for agents that possess both short-term hypnotic and anxiolytic properties whereas zolpidem solely exhibits hypnotic effects Midazolam a short-acting benzodiazepine is often used before anesthesia for its short-term hypnotic and anxiolytic effects Studies have found that midazolam oral solution is safe and effective for short-term use in clinical pre-surgical settings There are no studies on using oral midazolam solution to improve sleep and reduce anxiety in colorectal cancer patients before surgery Our previous research found that a dose of 72mg can effectively induce sleep with minimal side effects in 50 patients before surgery
In summary the present study intends to carry out a prospectiverandomizeddouble-blindplacebo-controlled clinical study to investigate the hypothesis that preoperative oral midazolam solution could reduce acute postoperative pain promote early recovery and reduce the risk of chronic pain in patients with poor sleep or anxiety before colorectal cancer surgery It is postulated that the potential benefits of preoperative oral midazolam solution may be attributed to decreased stress levels and lowered inflammation markers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None