PreoperativePOMPPRNCT06407518
Preoperative Oral Midazolam to Postoperative Pain Relief in Sleep Disturbance or Anxiety Patients With Colorectal Cancer
A study testing Midazolam oral solution in people with Preoperative and Sleep Disturbance, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Preoperative, Sleep Disturbance, Anxiety
- What is being tested?
- Midazolam oral solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 1 siteChina
- Study dates
- 24 Jul 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1. Signed of informed consent voluntarily; 2. Native Chinese speaker; 3. Age 18-60 years old, male or female; 4. BMI 18-30 kg/m2; 5. American Society of Anesthesiologists (ASA) grade 1 or 2, New York Heart Association (NYHA) gradeⅠor Ⅱ; 6. Non-emergency laparoscopic colorectal cancer resection; 7. General anesthesia with tracheal intubation; 8. Sleep disturbance (the Insomnia Severity Index,ISI≥15 ) or Anxiety (Generalized Anxiety Disorder scale-7,GAD-7≥10 ) from admission to surgery.
Who cannot join
- 1. Contraindications for Midazolam Oral Solution (According to the Instruction for Midazolam Oral Solution); 2. High risk of Obstructive Sleep Apnea Symptoms (Total score of STOP-Bang scale ≥3 points); 3. Suspected dementia (Total score of Mini-Mental State Examination (MMSE) according to years of education: 0 year≤19 points; 1~6 years≤22 points; above of 6 years≤26 points); 4. Severe depressive symptom within two weeks (Total score of Patient Health Questionnaire-9 (PHQ-9)≥15); 5. History of Neurological and Psychiatric diseases (According to the electronic medical record system); 6. History of Chronic Obstructive Pulmonary Disease (According to the electronic medical record system); 7. History of Heart Failure (According to the electronic medical record system); 8. Intestinal obstruction(The electronic medical record system records those who currently have any type of intestinal obstruction); 9. Liver and renal insufficiency; 10. Have taken opioids or drugs that act on the central nervous system within one week; 11. Take CYP3A4 isoenzyme inhibitors or inducers within one week (According to the Instruction for Midazolam Oral Solution); 12. Consume any alcoholic beverage within 24 hours; 13. Substance abusers (including alcohol, drugs or addictive substances); 14. Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655
SanQing Jin, MD, 0086-13719366863, jinsq@mail.sysu.edu.cn
About this study
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
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.
Read the detailed description
Preoperative sleep disturbance and anxiety worsen postoperative pain for patients undergoing surgeries. Research indicates that a significant proportion of patients, ranging from 8.8% to 79.1%, 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 individual's 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 7.2mg can effectively induce sleep with minimal side effects in 50% patients before surgery.
In summary, the present study intends to carry out a prospective,randomized,double-blind,placebo-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.
- Conditions
- Preoperative, Sleep Disturbance, Anxiety, Midazolam, Pain, Postoperative
- Being tested
- Midazolam oral solution, Placebo
- Keywords
- preoperative, oral midazolam, sleep disturbance, anxiety, postoperative pain, colorectal cancer
- Medical subject headings
- Parasomnias, Anxiety Disorders, Pain, Postoperative, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midazolam oral solutionDrug
Also called Midazolam oral solution, YICHANG HUMANWELL PHARMACEUTICAL
Each individual administers the midazolam oral solution nightly from enrollment to the surgry.
PlaceboOther
Each individual administers placebo solution nightly from enrollment to the surgry.
| Study group | Role | What they receive |
|---|---|---|
| Midazolam oral solution Group | Experimental | The intervention drug is midazolam oral solution at a dose of 7-10mg. The starting dosage is 7mg, with subsequent individual increases of 1mg up to a maximum dose of 10mg if patients do not achieve sleep within 30 minutes of administration. The individual dose wil be consistently maintained at the corresponding level every night until the surgery. Receives: Drug: Midazolam oral solution |
| Control Group | Placebo comparator | Placebo is a solution of midazolam oral solution that looks, tastes, and appears the same as the intervention drug, similar to the experimental group increment method. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of moderate to severe pain on the first postoperative day
NRS: Numerical Rating Scale, NRS pain score 0-3 for mild, 4-6 for moderate, 7-10 for severe; Moderate to severe pain: Mean NRS pain score ≥4; Mean NRS pain score: Mean pain is defined as the mean of NRS scores of the severest, lightest, average, and present pain within 24 hours using the Brief Pain Inventory Short version (BPIsf).
Measured: on the first postoperative day for Acute Postoperative Pain
Secondary outcomes (40)
Mean NRS pain score
NRS: Numerical Rating Scale, NRS pain score 0-3 for mild, 4-6 for moderate, 7-10 for severe; Mean NRS pain score: Mean pain is defined as the mean of NRS scores of the severest, lightest, average, and present pain within 24 hours using the Brief Pain Inventory Short version (BPIsf).
Measured: on the first postoperative day for Acute Postoperative Pain
Mean NRS pain score
NRS: Numerical Rating Scale, NRS pain score 0-3 for mild, 4-6 for moderate, 7-10 for severe; Mean NRS pain score: Mean pain is defined as the mean of NRS scores of the severest, lightest, average, and present pain within 24 hours using the Brief Pain Inventory Short version (BPIsf).
Measured: on the second postoperative day for Acute Postoperative Pain
Mean NRS pain score
NRS: Numerical Rating Scale, NRS pain score 0-3 for mild, 4-6 for moderate, 7-10 for severe; Mean NRS pain score: Mean pain is defined as the mean of NRS scores of the severest, lightest, average, and present pain within 24 hours using the Brief Pain Inventory Short version (BPIsf).
Measured: on the third postoperative day for Acute Postoperative Pain
Incidence of moderate to severe pain
NRS: Numerical Rating Scale, NRS pain score 0-3 for mild, 4-6 for moderate, 7-10 for severe; Moderate to severe pain: Mean NRS pain score ≥4; Mean NRS pain score: Mean pain is defined as the mean of NRS scores of the severest, lightest, average, and present pain within 24 hours using the Brief Pain Inventory Short version (BPIsf).
Measured: on the second postoperative day for Acute Postoperative Pain
Incidence of moderate to severe pain
NRS: Numerical Rating Scale, NRS pain score 0-3 for mild, 4-6 for moderate, 7-10 for severe; Moderate to severe pain: Mean NRS pain score ≥4; Mean NRS pain score: Mean pain is defined as the mean of NRS scores of the severest, lightest, average, and present pain within 24 hours using the Brief Pain Inventory Short version (BPIsf).
Measured: on the third postoperative day for Acute Postoperative Pain
The number of times analgesics being added
The number of additional postoperative analgesics, by Patient-Controlled Analgesia or prescribed by doctors
Measured: on the first postoperative day for Acute Postoperative Pain
The number of times analgesics being added
The number of additional postoperative analgesics, by Patient-Controlled Analgesia or prescribed by doctors
Measured: on the second postoperative day for Acute Postoperative Pain
The number of times analgesics being added
The number of additional postoperative analgesics, by Patient-Controlled Analgesia or prescribed by doctors
Measured: on the third postoperative day for Acute Postoperative Pain
Total scores of the questionnaire of 15-item Quality of Recovery scale
QoR-15: 15-item Quality of Recovery scale; QoR-15 is a patient-reported measure, and is used to assess global recovery quality after surgery physiologically and psychologically. QoR-15 contents 15 items, which item is constructed by an 11-point numerical rating scale (for positive items, 0="none of the time"to 10="all of the time"; for negative items the scoring are reversed). The total scores are ranging from 0(extremely poor QoR) to 150 (excellent QoR).
Measured: on the first postoperative day
Total scores of the questionnaire of 15-item Quality of Recovery scale
QoR-15: 15-item Quality of Recovery scale; QoR-15 is a patient-reported measure, and is used to assess global recovery quality after surgery physiologically and psychologically. QoR-15 contents 15 items, which item is constructed by an 11-point numerical rating scale (for positive items, 0="none of the time"to 10="all of the time"; for negative items the scoring are reversed). The total scores are ranging from 0(extremely poor QoR) to 150 (excellent QoR).
Measured: on the second postoperative day
Total scores of the questionnaire of 15-item Quality of Recovery scale
QoR-15: 15-item Quality of Recovery scale; QoR-15 is a patient-reported measure, and is used to assess global recovery quality after surgery physiologically and psychologically. QoR-15 contents 15 items, which item is constructed by an 11-point numerical rating scale (for positive items, 0="none of the time"to 10="all of the time"; for negative items the scoring are reversed). The total scores are ranging from 0(extremely poor QoR) to 150 (excellent QoR).
Measured: on the third postoperative day
Requirement for propofol when induction of general anesthesia
Propofol is titrated for the purpose of achieving general anesthesia prior to colorectal cancer resection. Upon reaching the titration endpoint, indicated by an OAAS sedation score of 0, the dosage of propofol administered (in mg/kg) is documented.
OAAS：Observer's Assessment Alertness/Sedation scale
Measured: on the day of colorectal cancer resection and general anesthesia
Incidence of post-anesthesia care unit (PACU) stays longer than 1 hour
Following the surgical procedure, the patient is relocated to the Post-Anesthesia Care Unit (PACU). Patients may be transferred to the general ward once their postoperative resuscitation meets established standards. Incidence of PACU stays longer than 1 hour is recorded.
Measured: on the day of colorectal cancer resection and general anesthesia
The amount of additional analgesics in PACU
The quantity of supplementary analgesic medications administered in PACU
Measured: on the day of colorectal cancer resection and general anesthesia
Incidence of fever in the first 72 hours after surgery
The incidence of axillary temperatures above 38℃ within 72 hours post-surgery is recorded.
Measured: In the third postoperative day
Length of hospital stay after surgery
Length of hospital stay after surgery：hospital stay time (days) from operation completion to actual hospital discharge
Measured: Days from operation completion to actual hospital discharge (expected 7 days after surgery)
The financial burden in the hospital after surgery
Medical costs from operation completion to actual hospital discharge
Measured: Days from operation completion to actual hospital discharge (expected 7 days after surgery)
Incidence of unplanned reoperations within 30 Days after Surgery
Incidence of unplanned reoperations within 30 Days after Surgery
Measured: within 30 days after surgery
Incidence of unplanned admissions within 30 Days after Surgery
Incidence of unplanned admissions within 30 Days after Surgery
Measured: within 30 days after surgery
Total score of The Brief Pain Inventory at the 30th day after surgery
The Brief Pain Inventory: to survey postoperative chronic pain after surgery
Measured: at the 30th day after surgery for chronic Postoperative Pain
Total score of The Brief Pain Inventory at the 90th day after surgery
The Brief Pain Inventory: to survey postoperative chronic pain after surgery
Measured: at the 90th day after surgery for chronic Postoperative Pain
Total score of SF-36 at the 30th day after surgery
SF-36: The short form (SF)-36 is an instrument to survey postoperative health status.
Measured: at the 30th day after surgery for postoperative health status
Total score of SF-36 at the 90th day after surgery
SF-36: The short form (SF)-36 is an instrument to survey postoperative health status.
Measured: at the 90th day after surgery for postoperative health status
Number of patients still taking pain medication on day 30 after surgery
Number of patients still taking pain medication on day 30 after surgery
Measured: on the 30th day after surgery
Number of patients still taking pain medication on day 90 after surgery
Number of patients still taking pain medication on day 90 after surgery
Measured: on the 90th day after surgery
Incidence of post-traumatic stress disorder (PTSD) at 30 days post-surgery
The prevalence of post-traumatic stress disorder as measured by the PC-PTSD scale at 30 days following surgical procedures.
PC- PTSD：Primary Care Post traumatic Stress Disorder
Measured: on the 30th day after surgery
Incidence of post-traumatic stress disorder (PTSD) at 90 days post-surgery
The prevalence of post-traumatic stress disorder as measured by the PC-PTSD scale at 90 days following surgical procedures.
PC- PTSD：Primary Care Post traumatic Stress Disorder
Measured: on the 90th day after surgery
The ratio of neutrophils to lymphocytes in peripheral blood on the first day after surgery
The ratio of neutrophils to lymphocytes in peripheral blood on the first day after surgery
Measured: on the first day after surgery
The ratio of neutrophils to lymphocytes in peripheral blood on the third day after surgery
The ratio of neutrophils to lymphocytes in peripheral blood on the third day after surgery
Measured: on the third day after surgery
The ratio of platelets to lymphocytes in peripheral blood on the first day after surgery
The ratio of platelets to lymphocytes in peripheral blood on the first day after surgery
Measured: on the first day after surgery
The ratio of platelets to lymphocytes in peripheral blood on the third day after surgery
The ratio of platelets to lymphocytes in peripheral blood on the third day after surgery
Measured: on the third day after surgery
C-reactive protein levels in peripheral blood on the first day after surgery
C-reactive protein levels in peripheral blood on the first day after surgery
Measured: on the first day after surgery
C-reactive protein levels in peripheral blood on the third day after surgery
C-reactive protein levels in peripheral blood on the third day after surgery
Measured: on the third day after surgery
Opioid consumption in milligrams of intravenous morphine equivalents within three days after surgery
Opioid consumption in milligrams of intravenous morphine equivalents within three days after surgery
Measured: within three days after surgery
Opioid consumption in milligrams of intravenous or oral morphine equivalents within 30 days after surgery
Opioid consumption in milligrams of intravenous or oral morphine equivalents within 30 days after surgery
Measured: within 30 days after surgery
Opioid consumption in milligrams of intravenous or oral morphine equivalents within 90 days after surgery
Opioid consumption in milligrams of intravenous or oral morphine equivalents within 90 days after surgery
Measured: within 90 days after surgery
Incidence of nausea (requiring treatment) and vomiting within three days after surgery
Incidence of nausea (requiring treatment) and vomiting within three days after surgery
Measured: within three days after surgery
Incidence of patients mobilising on the first day after surgery
Incidence of patients mobilising on the first day after surgery
Measured: on the first day after surgery
time until first flatus after surgery in days
time until first flatus after surgery in days
Measured: time until first flatus after surgery in days (generally, within the three days after surgery )
Incidence of complications related to surgery within 30 days after surgery
Incidence of complications related to surgery within 30 days after surgery [ complication grade according to Clavien-Dindo（No complications，Grade I-II，Grade IIIa + IIIb，Grade IV，Grade V）]
Measured: within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start24 Jul 2024
- Primary completionOct 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreoperativeStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SanQing Jin, Sixth Affiliated Hospital, Sun Yat-sen University
- Investigators
- sanqing Jin, MD, Principal investigator, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06407518
- Sponsor's protocol ID
- 2024ZSLYEC-351
- Acronym
- POMPPR
- Status last verified
- Apr 2025
- First submitted
- 2 May 2024
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06407518
- Acronym / sponsor ID
- POMPPR / 2024ZSLYEC-351
- Conditions
- Preoperative, Sleep Disturbance, Anxiety, Midazolam, Pain, Postoperative
- Keywords
- preoperative, oral midazolam, sleep disturbance, anxiety, postoperative pain, colorectal cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 24 Jul 2024 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 9 May 2024 (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.
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 8.8% to 79.1%, 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 individual's 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 7.2mg can effectively induce sleep with minimal side effects in 50% patients before surgery.
In summary, the present study intends to carry out a prospective,randomized,double-blind,placebo-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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Midazolam oral solution Group | Experimental | Drug: Midazolam oral solutionThe intervention drug is midazolam oral solution at a dose of 7-10mg. The starting dosage is 7mg, with subsequent individual increases of 1mg up to a maximum dose of 10mg if patients do not achieve sleep within 30 minutes of administration. The individual dose wil be consistently maintained at the corresponding level every night until the surgery. |
| Control Group | Placebo comparator | Other: PlaceboPlacebo is a solution of midazolam oral solution that looks, tastes, and appears the same as the intervention drug, similar to the experimental group increment method. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. Signed of informed consent voluntarily; 2. Native Chinese speaker; 3. Age 18-60 years old, male or female; 4. BMI 18-30 kg/m2; 5. American Society of Anesthesiologists (ASA) grade 1 or 2, New York Heart Association (NYHA) gradeⅠor Ⅱ; 6. Non-emergency laparoscopic colorectal cancer resection; 7. General anesthesia with tracheal intubation; 8. Sleep disturbance (the Insomnia Severity Index,ISI≥15 ) or Anxiety (Generalized Anxiety Disorder scale-7,GAD-7≥10 ) from admission to surgery.
Key exclusion criteria (1 listed)
- 1. Contraindications for Midazolam Oral Solution (According to the Instruction for Midazolam Oral Solution); 2. High risk of Obstructive Sleep Apnea Symptoms (Total score of STOP-Bang scale ≥3 points); 3. Suspected dementia (Total score of Mini-Mental State Examination (MMSE) according to years of education: 0 year≤19 points; 1~6 years≤22 points; above of 6 years≤26 points); 4. Severe depressive symptom within two weeks (Total score of Patient Health Questionnaire-9 (PHQ-9)≥15); 5. History of Neurological and Psychiatric diseases (According to the electronic medical record system); 6. History of Chronic Obstructive Pulmonary Disease (According to the electronic medical record system); 7. History of Heart Failure (According to the electronic medical record system); 8. Intestinal obstruction(The electronic medical record system records those who currently have any type of intestinal obstruction); 9. Liver and renal insufficiency; 10. Have taken opioids or drugs that act on the central nervous system within one week; 11. Take CYP3A4 isoenzyme inhibitors or inducers within one week (According to the Instruction for Midazolam Oral Solution); 12. Consume any alcoholic beverage within 24 hours; 13. Substance abusers (including alcohol, drugs or addictive substances); 14. Pregnant or lactating women.
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 |
|---|---|---|
| Midazolam oral solutionAlso: Midazolam oral solution, YICHANG HUMANWELL PHARMACEUTICALEach individual administers the midazolam oral solution nightly from enrollment to the surgry. | Drug | Midazolam oral solution Group |
| PlaceboEach individual administers placebo solution nightly from enrollment to the surgry. | Other | Control Group |
Primary outcome
Incidence of moderate to severe pain on the first postoperative day
Time frame: on the first postoperative day for Acute Postoperative Pain
NRS: Numerical Rating Scale, NRS pain score 0-3 for mild, 4-6 for moderate, 7-10 for severe; Moderate to severe pain: Mean NRS pain score ≥4; Mean NRS pain score: Mean pain is defined as the mean of NRS scores of the severest, lightest, average, and present pain within 24 hours using the Brief Pain Inventory Short version (BPIsf).
40 secondary outcomes
Mean NRS pain score
Time frame: on the first postoperative day for Acute Postoperative Pain
Mean NRS pain score
Time frame: on the second postoperative day for Acute Postoperative Pain
Mean NRS pain score
Time frame: on the third postoperative day for Acute Postoperative Pain
Incidence of moderate to severe pain
Time frame: on the second postoperative day for Acute Postoperative Pain
Incidence of moderate to severe pain
Time frame: on the third postoperative day for Acute Postoperative Pain
The number of times analgesics being added
Time frame: on the first postoperative day for Acute Postoperative Pain
The number of times analgesics being added
Time frame: on the second postoperative day for Acute Postoperative Pain
The number of times analgesics being added
Time frame: on the third postoperative day for Acute Postoperative Pain
Total scores of the questionnaire of 15-item Quality of Recovery scale
Time frame: on the first postoperative day
Total scores of the questionnaire of 15-item Quality of Recovery scale
Time frame: on the second postoperative day
Total scores of the questionnaire of 15-item Quality of Recovery scale
Time frame: on the third postoperative day
Requirement for propofol when induction of general anesthesia
Time frame: on the day of colorectal cancer resection and general anesthesia
Incidence of post-anesthesia care unit (PACU) stays longer than 1 hour
Time frame: on the day of colorectal cancer resection and general anesthesia
The amount of additional analgesics in PACU
Time frame: on the day of colorectal cancer resection and general anesthesia
Incidence of fever in the first 72 hours after surgery
Time frame: In the third postoperative day
Length of hospital stay after surgery
Time frame: Days from operation completion to actual hospital discharge (expected 7 days after surgery)
The financial burden in the hospital after surgery
Time frame: Days from operation completion to actual hospital discharge (expected 7 days after surgery)
Incidence of unplanned reoperations within 30 Days after Surgery
Time frame: within 30 days after surgery
Incidence of unplanned admissions within 30 Days after Surgery
Time frame: within 30 days after surgery
Total score of The Brief Pain Inventory at the 30th day after surgery
Time frame: at the 30th day after surgery for chronic Postoperative Pain
Total score of The Brief Pain Inventory at the 90th day after surgery
Time frame: at the 90th day after surgery for chronic Postoperative Pain
Total score of SF-36 at the 30th day after surgery
Time frame: at the 30th day after surgery for postoperative health status
Total score of SF-36 at the 90th day after surgery
Time frame: at the 90th day after surgery for postoperative health status
Number of patients still taking pain medication on day 30 after surgery
Time frame: on the 30th day after surgery
Number of patients still taking pain medication on day 90 after surgery
Time frame: on the 90th day after surgery
Incidence of post-traumatic stress disorder (PTSD) at 30 days post-surgery
Time frame: on the 30th day after surgery
Incidence of post-traumatic stress disorder (PTSD) at 90 days post-surgery
Time frame: on the 90th day after surgery
The ratio of neutrophils to lymphocytes in peripheral blood on the first day after surgery
Time frame: on the first day after surgery
The ratio of neutrophils to lymphocytes in peripheral blood on the third day after surgery
Time frame: on the third day after surgery
The ratio of platelets to lymphocytes in peripheral blood on the first day after surgery
Time frame: on the first day after surgery
The ratio of platelets to lymphocytes in peripheral blood on the third day after surgery
Time frame: on the third day after surgery
C-reactive protein levels in peripheral blood on the first day after surgery
Time frame: on the first day after surgery
C-reactive protein levels in peripheral blood on the third day after surgery
Time frame: on the third day after surgery
Opioid consumption in milligrams of intravenous morphine equivalents within three days after surgery
Time frame: within three days after surgery
Opioid consumption in milligrams of intravenous or oral morphine equivalents within 30 days after surgery
Time frame: within 30 days after surgery
Opioid consumption in milligrams of intravenous or oral morphine equivalents within 90 days after surgery
Time frame: within 90 days after surgery
Incidence of nausea (requiring treatment) and vomiting within three days after surgery
Time frame: within three days after surgery
Incidence of patients mobilising on the first day after surgery
Time frame: on the first day after surgery
time until first flatus after surgery in days
Time frame: time until first flatus after surgery in days (generally, within the three days after surgery )
Incidence of complications related to surgery within 30 days after surgery
Time frame: within 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- 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.
sanqing Jin, MD principal investigator
Sixth Affiliated Hospital, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Midazolam oral solution in people with Preoperative and Sleep Disturbance, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 6 Apr 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sanqing Jin, MD (0086-13719366863, jinsq@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of moderate to severe pain on the first postoperative day (time frame: on the first postoperative day for Acute Postoperative Pain). 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 6 Apr 2025.