Intra-operative BleedingNCT04095754
Can Head Position Improve Surgical Field During Ear Surgery?
A study testing Head-Up Position, Dexmedetomidine and Induction and maintenance of anaesthesia in people with Intra-operative Bleeding, run by Ain Shams University at 2 sites in Egypt.
Trial summary
Middle ear surgeries utilizes microscope in a narrow field. They are better performed under controlled hypotension, to minimize bleeding and improve surgical field visualization and hence improve results.Head-up or anti-trendelenburg position influences intraoperative bleeding by generating regional ischaemia in sites… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Intra-operative Bleeding
- What is being tested?
- Head-Up Position, Dexmedetomidine and Induction and maintenance of anaesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 2 sitesEgypt
- Study dates
- 12 Apr 2020to 14 Oct 2020
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA I-II
Who cannot join
- Patients with uncontrolled hypertension, coronary artery disease or on beta blockers.
- Cerebrovascular insufficiency.
- Anaemia.
- End stage renal failure.
- Liver cirrhosis.
- Patients with coagulopathy or receiving drugs influencing blood coagulation.
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- Pregnancy.
- Known sensitivity to any of the study drugs.
- Patients' refusal to participate in the study.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Ain Shams University Hospitals
Cairo, 11588
Ain Shams University
Cairo
About this study
Official title: Can Anti-Trendelenburg Position Improve Surgical Field Without Affecting Accessibility During Ear Surgery? A Randomized-Controlled Trial.
Middle ear surgeries utilizes microscope in a narrow field. They are better performed under controlled hypotension, to minimize bleeding and improve surgical field visualization and hence improve results.Head-up or anti-trendelenburg position influences intraoperative bleeding by generating regional ischaemia in sites elevated above the level of the heart. Also by augmenting the effect of vasodilators through pooling of blood in dilated veins.
Read the detailed description
After obtaining local ethical committee approval and written informed consent from the patients, 225 adult patients, scheduled for elective middle ear surgery in Ain Shams University hospitals will be enrolled in this randomized, prospective controlled study.
After applying basic monitors (ECG, pulse oximetry, non-invasive blood pressure monitoring and capnography), all patients will be premedicated with midazolam 0.02 mg.kg -1 IV and ranitidine 50 mg IV, 15 min. prior to surgery.
All patients will receive dexmedetomidine 1mcg. Kg-1 loading dose over 10 min just before induction, followed by continuous infusion of 0.4 mcg.kg-1hr-1. Rate of infusion will be adjusted to maintain MAP 20% below baseline. Dexmedetomidine infusion will be stopped after graft insertion. Total dexmedetomidine consumption will be recorded.
In the operating room and after 5 min preoxygenation, general anesthesia will be conducted using the same protocol for all patients: fentanyl 1 μg.Kg-1, propofol 1.5-2 mg.kg -1 titrated to loss of verbal response, atracurium 0.5 mg. Kg-1 to facilitate endotracheal intubation.
Anaesthesia will be maintained using isoflurane 1 % in oxygen and air mixture 1:1 and atracurium 0.1 mg. Kg-1 every 20 mim. Positive pressure ventilation will be set to maintain normocapnia.
Patients will be randomly and evenly assigned to one of three groups, 75 patients each.
Group I (control): Patients will be positioned supine. Group II: patients will be positioned 10° anti-trendelenburg position. Group III: patients will be positioned 20° anti-trendelenburg position. Randomization will be done using computer generated list. The anaesthesia nurse recording the data is blinded to the study groups.
At the end of surgery, isoflurane will be discontinued and residual neuromuscular blockade will be reversed. Recovery time will be recorded (Defined as: the time from discontinuation of volatile anaesthetic till the patient is able to respond to verbal command). Patients will then be transferred to PACU.
During surgery, if the surgeon found it difficult to complete the surgery in the anti-trendelenburg (groups II and III), surgery will be continued in the supine position. Patients will still be calculated in the pre-assigned group with recording of such event, and assuming surgeon satisfaction to be 5 in these patients.
- Conditions
- Intra-operative Bleeding
- Being tested
- Head-Up Position, Dexmedetomidine, Induction and maintenance of anaesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Head-Up PositionProcedure or surgery
Also called Anti-Trendelenburg Position
Anti-Trendelenburg Position
DexmedetomidineDrug
Also called controlled hypotension
Controlled hypotension: All patients will receive dexmedetomidine 1mcg. Kg-1 loading dose over 10 min just before induction, followed by continuous infusion of 0.4 mcg.kg-1hr-1
Induction and maintenance of anaesthesiaDrug
Also called Anaesthetic drugs
Induction of anaesthesia: fentanyl 1 μg.Kg-1, propofol 1.5-2 mg.kg -1 titrated to loss of verbal response, atracurium 0.5 mg. Kg-1 to facilitate endotracheal intubation.
Maintenance:Anaesthesia will be maintained using isoflurane 1 % in oxygen and air mixture 1:1 and atracurium 0.1 mg. Kg-1 every 20 mim.
| Study group | Role | What they receive |
|---|---|---|
| Group I (control group) | Other | Patients will be positioned supine. Receives: Drug: Dexmedetomidine; Drug: Induction and maintenance of anaesthesia |
| Group II | Experimental | patients will be positioned 10° anti-trendelenburg position. Receives: Procedure: Head-Up Position; Drug: Dexmedetomidine; Drug: Induction and maintenance of anaesthesia |
| Group III | Experimental | patients will be positioned 20° anti-trendelenburg position. Receives: Procedure: Head-Up Position; Drug: Dexmedetomidine; Drug: Induction and maintenance of anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of surgical field.
The surgeon, as well as the surgeon's assistant, will be asked to assess the surgical field using a 5-point scale: 1- no bleeding, 2- minimal bleeding, 3- bleeding easily controlled, 4- bleeding hindering work, 5- bleeding stops work.
Measured: Immediately after surgery.
Surgical position accessibility.
The surgeon satisfaction concerning suitability of patient's position will be evaluated using a 5-point scale: 1- excellent, 2- good, 3- acceptable, 4- bad, 5- very bad.
Measured: Immediately after surgery.
Secondary outcomes (5)
Total dexmedetomidine consumption.
The total dose of dexmedetomidine used for each patient
Measured: At the end of surgery
Surgical time
duration of surgery (skin to skin time)
Measured: At the end of surgery
Recovery time
the time from discontinuation of volatile anaesthetic till the patient is able to respond to verbal command
Measured: At the end of surgery
Sedation Score
Ramasay sedation score: will be assessed on arrival to the PACU, then every 30 min for the first 2 hours after surgery (1= anxious, agitation or restless; 2= cooperative, oriented, and tranquil; 3= responsive to commands; 4= asleep but with brisk response to light, glabellar tab, or loud auditory stimulus; 5= asleep, sluggish response to glabellar tab, or loud auditory stimulus; 6= asleep, no response).
Measured: on arrival to the PACU, then every 30 min for the first 2 hours after surgery
Analgesia time
time to first rescue analgesic required
Measured: first 12 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start12 Apr 2020
- Primary completion14 Oct 2020
- Study completion14 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intra-operative BleedingStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hala Salah El-Din El-Ozairy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04095754
- Sponsor's protocol ID
- FMASU R 49/2019
- Status last verified
- Oct 2020
- First submitted
- 13 Sep 2019
- Last updated
- 19 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All primery and secondary outcome data
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Anti-Trendelenburg Position Improve Surgical Field Without Affecting Accessibility During Ear Surgery? A Randomized-Controlled Trial.
- ClinicalTrials.gov ID
- NCT04095754
- Acronym / sponsor ID
- FMASU R 49/2019
- Conditions
- Intra-operative Bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 12 Apr 2020 (actual)
- Primary completion
- 14 Oct 2020 (actual)
- Study completion
- 14 Oct 2020 (actual)
- First posted
- 19 Sep 2019 (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.
Middle ear surgeries utilizes microscope in a narrow field. They are better performed under controlled hypotension, to minimize bleeding and improve surgical field visualization and hence improve results.Head-up or anti-trendelenburg position influences intraoperative bleeding by generating regional ischaemia in sites elevated above the level of the heart. Also by augmenting the effect of vasodilators through pooling of blood in dilated veins.
Detailed description
After obtaining local ethical committee approval and written informed consent from the patients, 225 adult patients, scheduled for elective middle ear surgery in Ain Shams University hospitals will be enrolled in this randomized, prospective controlled study.
After applying basic monitors (ECG, pulse oximetry, non-invasive blood pressure monitoring and capnography), all patients will be premedicated with midazolam 0.02 mg.kg -1 IV and ranitidine 50 mg IV, 15 min. prior to surgery.
All patients will receive dexmedetomidine 1mcg. Kg-1 loading dose over 10 min just before induction, followed by continuous infusion of 0.4 mcg.kg-1hr-1. Rate of infusion will be adjusted to maintain MAP 20% below baseline. Dexmedetomidine infusion will be stopped after graft insertion. Total dexmedetomidine consumption will be recorded.
In the operating room and after 5 min preoxygenation, general anesthesia will be conducted using the same protocol for all patients: fentanyl 1 μg.Kg-1, propofol 1.5-2 mg.kg -1 titrated to loss of verbal response, atracurium 0.5 mg. Kg-1 to facilitate endotracheal intubation.
Anaesthesia will be maintained using isoflurane 1 % in oxygen and air mixture 1:1 and atracurium 0.1 mg. Kg-1 every 20 mim. Positive pressure ventilation will be set to maintain normocapnia.
Patients will be randomly and evenly assigned to one of three groups, 75 patients each.
Group I (control): Patients will be positioned supine. Group II: patients will be positioned 10° anti-trendelenburg position. Group III: patients will be positioned 20° anti-trendelenburg position. Randomization will be done using computer generated list. The anaesthesia nurse recording the data is blinded to the study groups.
At the end of surgery, isoflurane will be discontinued and residual neuromuscular blockade will be reversed. Recovery time will be recorded (Defined as: the time from discontinuation of volatile anaesthetic till the patient is able to respond to verbal command). Patients will then be transferred to PACU.
During surgery, if the surgeon found it difficult to complete the surgery in the anti-trendelenburg (groups II and III), surgery will be continued in the supine position. Patients will still be calculated in the pre-assigned group with recording of such event, and assuming surgeon satisfaction to be 5 in these patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I (control group) | Other | Drug: Dexmedetomidine, Drug: Induction and maintenance of anaesthesiaPatients will be positioned supine. |
| Group II | Experimental | Procedure: Head-Up Position, Drug: Dexmedetomidine, Drug: Induction and maintenance of anaesthesiapatients will be positioned 10° anti-trendelenburg position. |
| Group III | Experimental | Procedure: Head-Up Position, Drug: Dexmedetomidine, Drug: Induction and maintenance of anaesthesiapatients will be positioned 20° anti-trendelenburg position. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ASA I-II
Key exclusion criteria (9 listed)
- Patients with uncontrolled hypertension, coronary artery disease or on beta blockers.
- Cerebrovascular insufficiency.
- Anaemia.
- End stage renal failure.
- Liver cirrhosis.
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 |
|---|---|---|
| Head-Up PositionAlso: Anti-Trendelenburg PositionAnti-Trendelenburg Position | Procedure or surgery | Group II, Group III |
| DexmedetomidineAlso: controlled hypotensionControlled hypotension: All patients will receive dexmedetomidine 1mcg. Kg-1 loading dose over 10 min just before induction, followed by continuous infusion of 0.4 mcg.kg-1hr-1 | Drug | Group I (control group), Group II, Group III |
| Induction and maintenance of anaesthesiaAlso: Anaesthetic drugsInduction of anaesthesia: fentanyl 1 μg.Kg-1, propofol 1.5-2 mg.kg -1 titrated to loss of verbal response, atracurium 0.5 mg. Kg-1 to facilitate endotracheal intubation. Maintenance:Anaesthesia will be maintained using isoflurane 1 % in oxygen and air mixture 1:1 and atracurium 0.1 mg. Kg-1 every 20 mim. | Drug | Group I (control group), Group II, Group III |
Primary outcome
Quality of surgical field.
Time frame: Immediately after surgery.
The surgeon, as well as the surgeon's assistant, will be asked to assess the surgical field using a 5-point scale: 1- no bleeding, 2- minimal bleeding, 3- bleeding easily controlled, 4- bleeding hindering work, 5- bleeding stops work.
Surgical position accessibility.
Time frame: Immediately after surgery.
The surgeon satisfaction concerning suitability of patient's position will be evaluated using a 5-point scale: 1- excellent, 2- good, 3- acceptable, 4- bad, 5- very bad.
5 secondary outcomes
Total dexmedetomidine consumption.
Time frame: At the end of surgery
Surgical time
Time frame: At the end of surgery
Recovery time
Time frame: At the end of surgery
Sedation Score
Time frame: on arrival to the PACU, then every 30 min for the first 2 hours after surgery
Analgesia time
Time frame: first 12 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Individual participant dataSharing planned: Yes. All primery and secondary outcome data
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Head-Up Position, Dexmedetomidine and Induction and maintenance of anaesthesia in people with Intra-operative Bleeding, run by Ain Shams University at 2 sites 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 1 inclusion and 9 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: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of surgical field. (time frame: Immediately after surgery.). 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 19 Oct 2020.