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104 patients who undergo painless colonoscopy from January 20,2024 to February 29,2024 will be randomized to two groups: propofol group and dexmedetomidine group.
In the dexmedetomidine group,dexmedetomidine is infusion intravenously with a loading dose of 0.5 μg kg-1 for 10 min, then infusion at 0.3 μg kg-1 h-1 according to the ideal body weight of the patient until the end of colonoscopy. In the propofol group, Propofol is administrated 1 mg kg-1 intravenously, then titrated given by 0.5 mg kg-1 during the whole process.
104 patients who undergo painless colonoscopy from January 20,2024 to February 29,2024 will be randomized to two groups: propofol group and dexmedetomidine group.
In the dexmedetomidine group,dexmedetomidine is infusion intravenously with a loading dose of 0.5 μg kg-1 for 10 min, then infusion at 0.3 μg kg-1 h-1 according to the ideal body weight of the patient until the end of colonoscopy. In the propofol group, Propofol is administrated 1 mg kg-1 intravenously, then titrated given by 0.5 mg kg-1.For all patients, if Ramsay sedation scale score reach 3, colonoscope will be inserted. During the whole process, maintenance Ramsay score of 3 to 4. Propofol 10 mg will be administrated as the rescue dose if body movement occur during colonoscopy.
The primary outcome is the occurrence of hypotension. Key secondary outcomes are time-weighted average (TWA), area under the threshold (AUT) and cumulative duration of hypotension, as well as the maximum reduction in BP. Other secondary outcomes include(1) the incidence of bradycardia, hypoxemia or body movement；(2) discharge time (from the end of colonoscopy to discharge); (3) patients and endoscopists' satisfaction score (using an 11-point Likert scale, with 0 indicating "very dissatisfied" and 10 indicating "very satisfied"); (4) the incidence of dizziness, fatigue, or nausea and vomiting
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine group | Experimental | Dexmedetomidine is infusion intravenously with a loading dose of 0.5 μg kg-1 for 10 min, then infusion at 0.3 μg kg-1 h-1 according to the ideal body weight of the patient until the end of colonoscopy. If Ramsay sedation scale score reach 3, colonoscope will be inserted. During the whole process, maintenance Ramsay score of 3 to 4. Propofol 10 mg will be administrated as the rescue dose if body movement occur during colonoscopy. |
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| Propofol group | Other | Propofol is administrated 1 mg kg-1 intravenously, then titrated given by 0.5 mg kg-1 until Ramsay score reach 3. During the whole process, propofol is given intermittently to maintain Ramsay score 3 to 4. If body movement happen, propofol 10mg will be administrated every time. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | In the dexmedetomidine group, dexmedetomidine is infusion intravenously with a loading dose of 0.5 μg kg-1 for 10 min, then infusion at 0.3 μg kg-1 h-1 according to the ideal body weight of the patient until the end of colonoscopy. During the whole process, maintenance Ramsay score of 3 to 4. Propofol 10 mg will be administrated as the rescue dose if body movement occur during colonoscopy. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome is the incidence of hypotension | Hypotension is defined as 20% decrease from baseline systolic blood pressure (SBP) or diastolic blood pressure (DBP), or SBP < 90, and/or DBP < 50 mmHg | The time during colonoscopy, an average of 15 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the threshold (AUT) of hypotension | AUT=depth of hypotension below (a 20% decrease in baseline SBP or DBP) or (90 mm Hg of SBP or 50 mm Hg of DBP)× time in minutes spent of hypotension. As an example, a patient undergoes colonoscopy that lasts 15 min, in which he experiences 2 episodes of hypotension, all lasting for 1 min and all with a minimal SBP of 80 mm Hg. The AUT = 2 min × (90 -80= 10 mm Hg under the SBP threshold of 90 mm Hg) = 2×10 = 20 mm Hg per minute. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Zhou | Contact | 18980606160 | zlmz@wchscu.cn | |
| Mao Ye | Contact | 13540432883 | 838915882@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Li Zhou | China, Sichuan West China Hospital | Study Chair |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Propofol | Drug | Propofol is administrated 1 mg kg-1 intravenously, then titrated given by 0.5 mg kg-1 until Ramsay score reach 3. During the whole process, propofol is given intermittently to maintain Ramsay score 3 to 4. If body movement happen, propofol 10mg will be administrated every time. |
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| The time during colonoscopy, an average of 15 minutes |
| Time-weighted average (TWA) | TWA is calculated as the AUT divided by the total duration of colonoscopy | The time during colonoscopy, an average of 15 minutes |
| Cumulative duration of hypotension | The total time of patients experience hypotenion（hpotension defined as 20% decrease from baseline systolic blood pressure (SBP) or diastolic blood pressure (DBP), or SBP < 90, and/or DBP < 50 mmHg) | The time during colonoscopy, an average of 15 minutes |
| Maximum reduction in blood pressure (BP) | Maximum reduction in systolic blood pressure (SBP) ,diastolic blood pressure (DBP) and mean arterial pressure (MAP) from baseline | The time during colonoscopy, an average of 15 minutes |
| The incidence of bradycardia | Bradycardia is defined as heat rate(HR) <50 beats/min | The time during colonoscopy, an average of 15 minutes |
| The incidence of hypoxemia | Hypoxemia is defined as oxygen saturation (SpO2)<90% | The time during colonoscopy, an average of 15 minutes |
| The body movement | The twisting of the patient's body due to the stimulation of the colonoscopy, making it difficult to proceed with the procedure | The time during colonoscopy, an average of 15 minutes |
| Discharge time | From the end of colonoscopy to discharge | From the end of colonoscopy to discharge，an average of 40 minutes |
| Patients satisfaction score | Using an 11-point Likert scale, with 0 indicating "very dissatisfied" and 10 indicating "very satisfied" | When the patient is fully awake after colonoscopy，an average of 5 minutes |
| Endoscopists'satisfaction score | Using an 11-point Likert scale, with 0 indicating "very dissatisfied" and 10 indicating "very satisfied" | At the end of colonoscopy,an average of 15 minutes |
| The incidence of dizziness | The investigators consider it dizziness if patients fell any dizziness | From the end of colonoscopy to discharge，an average of 40 minutes |
| The incidence of fatigue | The investigators consider it fatigue if patients fell any fatigue | From the end of colonoscopy to discharge，an average of 40 minutes |
| The incidence of nausea and vomiting | The investigators consider it nausea and vomiting if patients fell any nausea and vomiting | From the end of colonoscopy to discharge，an average of 40 minutes |
| D010636 |
| Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |