Can Head Position Improve Surgical Field During Ear Surgery?

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.

Study Overview

• Status: Completed
• Conditions: Intra-operative Bleeding
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Induction and maintenance of anaesthesia; Procedure: Head-Up Position

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 Type: Interventional
• Enrollment (Actual): 225
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shams University
  • Cairo, Egypt, 11588
    • Ain Shams University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group I (control group); Patients will be positioned supine.	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; Other Names: controlled hypotension; Drug: 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.; Other Names: Anaesthetic drugs
Experimental: Group II; patients will be positioned 10° 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; Other Names: controlled hypotension; Drug: 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.; Other Names: Anaesthetic drugs; Procedure: Head-Up Position; Anti-Trendelenburg Position; Other Names: Anti-Trendelenburg Position
Experimental: Group III; patients will be positioned 20° 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; Other Names: controlled hypotension; Drug: 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.; Other Names: Anaesthetic drugs; Procedure: Head-Up Position; Anti-Trendelenburg Position; Other Names: Anti-Trendelenburg Position

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2020
• Primary Completion (Actual): October 14, 2020
• Study Completion (Actual): October 14, 2020

Study Registration Dates

• First Submitted: September 13, 2019
• First Submitted That Met QC Criteria: September 17, 2019
• First Posted (Actual): September 19, 2019

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 14, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Intraoperative Complications; Blood Loss, Surgical; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Anesthetics; Dexmedetomidine
• Other Study ID Numbers: FMASU R 49/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All primery and secondary outcome data
• IPD Sharing Time Frame: After the publication of the study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No