Impact of Anesthesia Maintenance Methods on Incidence of Postoperative Delirium
- Conditions
- DeliriumPostoperative ComplicationsPostoperative Cognitive Dysfunction
- Interventions
- Registration Number
- NCT02662257
- Lead Sponsor
- Peking University First Hospital
- Brief Summary
Surgery is one of the major treatment methods for patients with malignant tumor. And, alone with ageing process, more and more elderly patients undergo surgery for malignant tumor. Evidence emerges that choice of anesthetics, i.e., either inhalational or intravenous anesthetics, may influence the outcome of elderly patients undergoing cancer surgery. Delirium is a commonly occurred early postoperative cognitive complication in the elderly, and its occurrence is associated with the worsening outcomes. Choice anesthetics may influence the occurrence of postoperative delirium. However, evidence in this aspect is conflicting.
- Detailed Description
It is estimated that 234.2 million major surgical procedures are undertaken every year worldwide. Surgery is one of the major treatment methods for patients with malignant tumor. And, alone with ageing process, more and more elderly patients undergo surgery for malignant tumor. Evidence emerges that choice of anesthetics, i.e., either inhalational or intravenous anesthetics, may influence the outcome of elderly patients undergoing cancer surgery.
Delirium is a commonly occurred cognitive complication in elderly patients after surgery. The occurrence of delirium is associated with the worsening outcomes, including increased morbidity and mortality, prolonged hospital stay, elevated medical care cost, and declined cognitive function. High age, major surgery, and critical illness are major risk factors of postoperative delirium (POD). However, the relationship between use of general anesthetics and occurrence of delirium cannot be excluded.
There are studies that compared the effects of two kinds of anesthetics on the cognitive outcomes after surgery. In the study of Nishikawa et al., 50 elderly (≥ 65 years) patients undergoing long-duration laparoscope-assisted surgery randomly received sevoflurane or propofol anesthesia. The results showed that, although the incidence of POD was not significantly different between the two groups, the delirium rating scale (DRS) score was significantly lower in the sevoflurane group than in the propofol group at postoperative days 2-3 (P = 0.007 and 0.002, respectively). In the study of Schoen et al., 128 patients undergoing on-pump cardiac surgery were randomized into two groups. The results showed that early postoperative cognitive function was significantly better in sevoflurane group than in the propofol group, especially in those who experienced cerebral desaturation during surgery.
On the other hand, some studies reported contrary results. In a large sample size study of 2000 patients undergoing general anesthesia, patients carrying ApoE4 epsilon 4 allele were more likely to develop early postoperative cognitive decline after inhalational anesthesia (odd ratio 3.31, 95% confidence interval 1.25-6.39, P \< 0.05), but not after intravenous anesthesia (odd ratio 0.93, 95% confidence interval 0.37-2.39, P \> 0.05). In a randomized control trail of 44 patients undergoing carotid endarterectomy, the mini-mental state examination (MMSE) score was significantly higher, whereas blood S100B concentration was significantly lower in the propofol group than in the sevoflurane group at 24 hours after surgery. In the study of Tang et al., 200 elderly (≥ 60 years) patients with mild cognitive impairment who planned to undergo radical rectal resection randomly received either sevoflurane or propofol anesthesia. The results showed that, although there was no difference in the incidence of cognitive dysfunction at 7 days after surgery, the negative cognitive effects was more severe after sevoflurane anesthesia than after propofol anesthesia (P = 0.01).
It seems that more evidence suggests the harmful cognitive effects of inhalational anesthetics. However, care must be taken when explaining these results: (1) target patients population were different; (2) sample size were small in the majority of studies; (3) the diagnostic criteria of cognitive complications were different, make it hard to do meta-analysis; (4) the clinical significance the of early postoperative cognitive complication remains to be elucidated.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1228
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Propofol group Propofol Propofol will be administered by intravenous infusion for anesthesia maintenance. The infusion rate of propofol will be adjusted to maintain the BIS value between 40 and 60. Analgesia will be supplemented with remifentanil (administered by continuous infusion), sufentanil (administered by intermittent injection/continuous infusion), or fentanyl (administered by intermittent injection). Towards the end of surgery, propofol infusion rate will be decreased and fentanyl/sufentanil will be administered when necessary. Propofol infusion will be stopped at the end of surgery. Sevoflurane group Sevoflurane Sevoflurane will be administered by inhalation for anesthesia maintenance. The concentration of inhaled sevoflurane will be adjusted to maintain the bispectral index (BIS) value between 40 and 60. Analgesia will be supplemented with remifentanil (administered by continuous infusion), sufentanil (administered by intermittent injection/continuous infusion), or fentanyl (administered by intermittent injection). Towards the end of surgery, sevoflurane inhalational concentration will be decreased and fentanyl/sufentanil will be administered when necessary. Sevoflurane inhalation will be stopped at the end of surgery.
- Primary Outcome Measures
Name Time Method Incidence of delirium within 7 days after surgery. Up to 7 days after surgery Delirium is assessed twice daily (8-10 AM and 6-8 PM) with the Confusion Assessment Method for patients without endotracheal intubation or the Confusion Assessment Method for the Intensive Care Unit for patients with endotracheal intubation.
- Secondary Outcome Measures
Name Time Method Cognitive function at 30 days after surgery. On the 30th day after surgery. Cognitive function assessed with Telephone Interview for Cognitive Status-Modified (TICS-m).
Percentage of intensive care unit (ICU) admission after surgery. Within 24 hours after surgery. Percentage of intensive care unit (ICU) admission after surgery.
Percentage of ICU admission with endotracheal intubation after surgery. Within 24 hours after surgery. Percentage of ICU admission with endotracheal intubation after surgery.
Length of stay in ICU after surgery. Up to 30 days after surgery. Length of stay in ICU after surgery (in patients admitted to the ICU after surgery).
Length of stay in hospital after surgery. Up to 30 days after surgery. Length of stay in hospital after surgery.
Incidence of non-delirium complications within 30 days. Up to 30 days after surgery. Non-delirium complications are defined as newly occurred events other than delirium that are harmful to patients' recovery and required therapeutic intervention, i.e., grade 2 or higher on the Clavien-Dindo classification.
Trial Locations
- Locations (17)
Cancer Hospital of Guangxi Medical University
🇨🇳Nanning, Guangxi, China
Peking University Cancer Hospital
🇨🇳Beijing, Beijing, China
Peking University School and Hospital of Stomatology
🇨🇳Beijing, Beijing, China
Guizhou Provincial People's Hospital
🇨🇳Guiyang, Guizhou, China
Hebei Medical University Forth Hospital
🇨🇳Shijiazhuang, Hebei, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
The Third Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Shaanxi Provincial People's Hospital
🇨🇳Taiyuan, Shanxi, China
Shanxi Province Cancer Hospital
🇨🇳Taiyuan, Shanxi, China
Tianjin Nankai Hospital
🇨🇳Tianjin, China
Tang-Du Hospital
🇨🇳Xi'an, Shaanxi, China
Beijing Shijitan Hospital
🇨🇳Beijing, Beijing, China
Shenzhen Second People's Hospital
🇨🇳Shenzhen, Guangzhou, China
Zhongda Hospital
🇨🇳Nanjing, Jiangsu, China
Affiliated Hospital of Qinghai University
🇨🇳Xining, Qinghai, China
Ningxia People's Hospital
🇨🇳Yinchuan, Ningxia, China
Peking University First Hospital
🇨🇳Beijing, Beijing, China