Can Head Position Improve Surgical Field During Ear Surgery?

Intra-operative Bleeding Clinical Trial

Official title:

Can Anti-Trendelenburg Position Improve Surgical Field Without Affecting Accessibility During Ear Surgery? A Randomized-Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04095754
• Other study ID #: FMASU R 49/2019
• Status: Completed
• Phase: N/A
• Start date: April 12, 2020
• Est. completion date: October 14, 2020

Study information

• Verified date: October 2020
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 elevated above the level of the heart. Also by augmenting the effect of vasodilators through pooling of blood in dilated veins.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: October 14, 2020
• Est. primary completion date: October 14, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• ASA I-II

Exclusion Criteria:

• 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.

• Pregnancy.

• Known sensitivity to any of the study drugs.

• Patients' refusal to participate in the study.

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Intra-operative Bleeding

Intervention

Procedure:
• Head-Up Position
Anti-Trendelenburg Position

Drug:
• Dexmedetomidine
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 anaesthesia
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.

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo
Egypt	Ain Shams University Hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Immediately after surgery.
Primary	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.	Immediately after surgery.
Secondary	Total dexmedetomidine consumption.	The total dose of dexmedetomidine used for each patient	At the end of surgery
Secondary	Surgical time	duration of surgery (skin to skin time)	At the end of surgery
Secondary	Recovery time	the time from discontinuation of volatile anaesthetic till the patient is able to respond to verbal command	At the end of surgery
Secondary	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).	on arrival to the PACU, then every 30 min for the first 2 hours after surgery
Secondary	Analgesia time	time to first rescue analgesic required	first 12 hours after surgery